journal
MENU ▼
Read by QxMD icon Read
search

Clinical Pharmacology in Drug Development

journal
https://www.readbyqxmd.com/read/28816033/selection-of-12-hour-sustained-release-acetaminophen-paracetamol-formulation-through-comparison-of-pharmacokinetic-profiles-of-4-sustained-release-prototype-formulations-and-standard-acetaminophen-formulation-an-open-label-randomized-proof-of-principle-pharmacokinetic
#1
Yong Yue, Dongzhou J Liu
Acetaminophen (APAP; paracetamol), a widely used analgesic and antipyretic, is available in modified-release and immediate-release (IR) formulations requiring 3- or 4-times-daily dosing. This phase 1 open-label crossover study compared pharmacokinetic profiles of single 2000-mg doses of 4 different sustained-release (SR) formulations of APAP (designed to allow twice-daily dosing) against two 1000-mg doses (taken 6 hours apart) of standard IR APAP in 14 healthy volunteers. The primary end point was duration of time that plasma APAP concentration exceeded a plasma concentration (TC ) of 4 μg/mL...
August 16, 2017: Clinical Pharmacology in Drug Development
https://www.readbyqxmd.com/read/28816026/evaluation-of-a-12-hour-sustained-release-acetaminophen-paracetamol-formulation-a-randomized-3-way-crossover-pharmacokinetic-and-safety-study-in-healthy-volunteers
#2
Yong Yue, Agron Collaku, Dongzhou J Liu
Acetaminophen (paracetamol) is a first-line treatment for mild and moderate pain. A twice-daily sustained-release (SR) formulation may be more convenient for chronic users than standard immediate-release (IR) acetaminophen. This randomized, 3-way crossover study evaluated pharmacokinetics and safety of single-dose 1500- and 2000-mg SR acetaminophen formulations and 2 doses of IR acetaminophen 1000 mg given 6 hours apart in healthy adults (n = 14). Primary outcome was time that plasma acetaminophen concentration was ≥4 μg/mL (TC≥4μg/mL )...
August 16, 2017: Clinical Pharmacology in Drug Development
https://www.readbyqxmd.com/read/28815997/bioequivalence-and-safety-of-twice-daily-sustained-release-paracetamol-acetaminophen-compared-with-3-and-4-times-daily-paracetamol-a-repeat-dose-crossover-pharmacokinetic-study-in-healthy-volunteers
#3
Dongzhou J Liu, Agron Collaku
Twice-daily sustained-release (SR) paracetamol (acetaminophen) offers convenient administration to chronic users. This study investigated at steady state (during the last 24 hours of a 3-day dosing period) the pharmacokinetics, bioequivalence, and safety of twice-daily SR paracetamol compared with extended-release (ER) and immediate-release (IR) paracetamol. In this open-label, randomized, multidose, 3-way crossover study, 28 healthy subjects received paracetamol SR (2 × 1000 mg twice daily), ER (2 × 665 mg 3 times daily), and IR (2 × 500 mg 4 times daily)...
August 16, 2017: Clinical Pharmacology in Drug Development
https://www.readbyqxmd.com/read/28800211/pharmacokinetics-and-bioequivalence-of-branded-and-generic-formulations-of-dofetilide-0-5-mg-capsules-after-single-dose-administration-in-healthy-subjects
#4
James T VanderLugt, Charles Bon, Dean Knuth, Rhonda Schreiber, Michael D Ruff
Class III antiarrhythmics are preferred therapy for managing atrial fibrillation/flutter. Dofetilide 0.5-mg capsules were US Food and Drug Administration (FDA) approved in 1999 to treat atrial fibrillation/flutter. Bioequivalence of generic dofetilide is important for treating arrhythmias because drug concentrations must be consistent to maintain normal sinus rhythm. Generic dofetilide 0.5-mg capsule pharmacokinetics were compared with branded product in 2 open-label, 2-way crossover, single-dose studies - 1 study each in fasted and fed healthy subjects...
August 11, 2017: Clinical Pharmacology in Drug Development
https://www.readbyqxmd.com/read/28800206/relative-bioavailability-of-fixed-dose-combinations-of-tamsulosin-and-dutasteride-results-from-2-randomized-trials-in-healthy-male-volunteers
#5
Olivia Burns, John Zhu, Michael J Manyak, Ramiya Ravindranath, Fariba Koosha, Nazneen Haque, Sally Chung
The relative bioavailabilities of dutasteride/tamsulosin hydrochloride 0.5 mg/0.2 mg fixed-dose combination (FDC) capsules compared with coadministered reference products (1 dutasteride 0.5-mg capsule [Avodart(®) ] + 1 tamsulosin hydrochloride 0.2-mg orally disintegrating tablet [Harnal D(®) ]) were investigated in 2 clinical trials under fasted and fed conditions (ClinicalTrials.gov NCT02184585 and NCT02509104). Both trials were open-label, randomized, single-dose, crossover studies in healthy male adults aged 18-65 years...
August 11, 2017: Clinical Pharmacology in Drug Development
https://www.readbyqxmd.com/read/28783873/luseogliflozin-an-sglt2-inhibitor-in-japanese-patients-with-mild-moderate-hepatic-impairment-a-pharmacokinetic-study
#6
Yoshishige Samukawa, Michio Sata, Kenichi Furihata, Toshifumi Ito, Naohiko Ueda, Hidekazu Ochiai, Soichi Sakai, Yuji Kumagai
This open-label, parallel-group study evaluated the effect of mild and moderate hepatic impairment on the pharmacokinetics of a single dose of luseogliflozin in Japanese subjects. Thirteen subjects with hepatic impairment (mild, n = 8; moderate, n = 5) and 6 healthy subjects received a single 5-mg dose of luseogliflozin. Serial blood sampling over 72 hours and 24-hour urine collection were done for pharmacokinetic analysis of luseogliflozin and its metabolites and to measure pharmacokinetic and pharmacodynamic parameters, respectively...
August 7, 2017: Clinical Pharmacology in Drug Development
https://www.readbyqxmd.com/read/28783872/evaluation-of-potential-drug-drug-interaction-between-delayed-release-dimethyl-fumarate-and-a-commonly-used-oral-contraceptive-norgestimate-ethinyl-estradiol-in-healthy-women
#7
Bing Zhu, Ivan Nestorov, Guolin Zhao, Venkata Meka, Mark Leahy, Jeanelle Kam, Sarah I Sheikh
Delayed-release dimethyl fumarate (DMF) is an oral therapy for relapsing multiple sclerosis with anti-inflammatory and neuroprotective properties. This 2-period crossover study was conducted to evaluate the potential for drug-drug interaction between DMF (240 mg twice daily) and a combined oral contraceptive (OC; norgestimate 250 μg, ethinyl estradiol 35 μg). Forty-six healthy women were enrolled; 32 completed the study. After the lead-in period (OC alone), 41 eligible participants were randomized 1:1 to sequence 1 (OC and DMF coadministration in period 1; OC alone in period 2) or sequence 2 (regimens reversed)...
August 7, 2017: Clinical Pharmacology in Drug Development
https://www.readbyqxmd.com/read/28783871/cardiac-safety-of-ozanimod-a-novel-sphingosine-1-phosphate-receptor-modulator-results-of-a-thorough-qt-qtc-study
#8
Jonathan Q Tran, Jeffrey P Hartung, Allan D Olson, Boaz Mendzelevski, Gregg A Timony, Marcus F Boehm, Robert J Peach, Sheila Gujrathi, Paul A Frohna
Ozanimod is a novel, selective, oral sphingosine-1-phosphate (1 and 5) receptor modulator in development for multiple sclerosis and inflammatory bowel disease. This randomized, double-blind, placebo-controlled, positive-controlled, parallel-group thorough QT study characterized the effects of ozanimod on cardiac repolarization in healthy subjects. Eligible subjects were randomized to 1 of 2 groups: ozanimod (escalated from 0.25 to 2 mg over 14 days) or placebo (for 14 days). A single dose of moxifloxacin 400 mg or placebo was administered on days 2 and 17...
August 7, 2017: Clinical Pharmacology in Drug Development
https://www.readbyqxmd.com/read/28763575/cardiac-safety-of-rupatadine-in-a-single-ascending-dose-and-multiple-ascending-dose-study-in-healthy-japanese-subjects-using-intensive-electrocardiogram-assessments-comparison-with-the-previous-white-caucasian-thorough-qt-study
#9
J Täubel, G Ferber, S Fernandes, E Santamaría, I Izquierdo
A thorough QT/QTc study in healthy white Caucasian subjects demonstrated that rupatadine has no proarrhythmic potential and raised no cardiac safety concerns. The present phase 1 study aimed to confirm the cardiac safety of rupatadine in healthy Japanese subjects. In this randomized, double-blind, placebo-controlled study, 27 healthy Japanese subjects were administered single and multiple escalating rupatadine doses of 10, 20, and 40 mg or placebo. Triplicate electrocardiogram (ECG) recordings were performed on days -1, 1, and 5 at several points, and time-matched pharmacokinetic samples were also collected...
August 1, 2017: Clinical Pharmacology in Drug Development
https://www.readbyqxmd.com/read/28750160/two-phase-1-open-label-mass-balance-studies-to-determine-the-pharmacokinetics-of-14-c-labeled-isavuconazonium-sulfate-in-healthy-male-volunteers
#10
Robert Townsend, Kota Kato, Christine Hale, Donna Kowalski, Christopher Lademacher, Takao Yamazaki, Shahzad Akhtar, Amit Desai
Isavuconazonium sulfate is the water-soluble prodrug of the active triazole isavuconazole. Two phase 1 studies were conducted to identify the metabolic profile and mass balance of isavuconazole and BAL8728 (inactive cleavage product). Seven subjects in study 1 (isavuconazole mass balance) received a single oral dose of [cyano-(14) C]isavuconazonium sulfate corresponding to 200 mg isavuconazole. Six subjects in study 2 (BAL8728 mass balance) received a single intravenous dose of [pyridinylmethyl-(14) C]isavuconazonium sulfate corresponding to 75 mg BAL8728...
July 27, 2017: Clinical Pharmacology in Drug Development
https://www.readbyqxmd.com/read/28741311/some-methodologic-considerations-in-the-assessment-of-methods-for-predicting-pharmacokinetic-drug-drug-interactions
#11
Dennis A Noe
No abstract text is available yet for this article.
July 24, 2017: Clinical Pharmacology in Drug Development
https://www.readbyqxmd.com/read/28741304/theranos-experience-exposes-weaknesses-in-fda-regulatory-discretion
#12
Rohan Jotwani, Marcia Boumil, Deeb Salem, Madeline Wetterhahn, Paul Beninger
No abstract text is available yet for this article.
July 24, 2017: Clinical Pharmacology in Drug Development
https://www.readbyqxmd.com/read/28724202/population-pharmacokinetics-of-lenalidomide-in-healthy-volunteers-and-patients-with-hematologic-malignancies
#13
Jamie N Connarn, Renfang Hwang, Yue Gao, Maria Palmisano, Nianhang Chen
A population pharmacokinetic (PopPK) model of lenalidomide was developed using data pooled from 13 clinical studies (dose range, 5-400 mg) in participants who were considered to have adequate capability for renal excretion of lenalidomide (creatinine clearance [CrCl] > 50 mL/min). The analysis population included 305 healthy volunteers and 83 patients with multiple myeloma or myelodysplastic syndromes. A 1-compartment model with linear absorption and elimination described well the observed data for both healthy volunteers and patients...
July 19, 2017: Clinical Pharmacology in Drug Development
https://www.readbyqxmd.com/read/28628269/effect-of-food-intake-on-the-pharmacokinetics-of-a-novel-methylphenidate-extended-release-oral-suspension-for-attention-deficit-hyperactivity-disorder
#14
Floyd R Sallee, Donna R Palumbo, Richat Abbas, Sally A Berry, Shivanand P Puthli, Kalyan K Kathala
We conducted an open-label, single-dose, randomized, crossover study in healthy adults to assess the impact of food on the bioavailability of 60 mg methylphenidate extended-release oral suspension (MEROS; Quillivant XR™)-a long-acting stimulant for the treatment of attention deficit hyperactivity disorder-by comparing the pharmacokinetic parameters under fed and fasting conditions. When MEROS 60 mg was administered under fed conditions compared with fasting conditions, the exposure of methylphenidate (d enantiomer) was higher, with a mean area under the plasma concentration-vs-time curve (AUC)0-t of 160...
June 19, 2017: Clinical Pharmacology in Drug Development
https://www.readbyqxmd.com/read/28597973/safety-tolerability-and-pharmacokinetics-of-single-and-multiple-oral-doses-of-an-omega-3-carboxylic-acid-formulation-in-healthy-male-japanese-subjects-a-phase-1-single-blind-randomized-placebo-controlled-trial
#15
Yoshinori Noda, Catarina Nilsson, Hitoshi Shimada, Hyosung Kim, Torbjörn Lundström, Toshitaka Yajima
OM3-CA (omega-3-carboxylic acids) is a complex mixture of omega-3 carboxylic acids, particularly eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), which is approved in the United States for the treatment of hypertriglyceridemia. As part of its clinical development in Japan, we performed a phase 1 study to investigate the safety, tolerability, and pharmacokinetics after single and multiple doses of OM3-CA in healthy male Japanese subjects. Eighteen Japanese subjects were allocated to receive 2 or 4 g/day OM3-CA, or placebo (n = 6 per group)...
June 9, 2017: Clinical Pharmacology in Drug Development
https://www.readbyqxmd.com/read/28581645/effects-of-a-nutritional-protein-rich-drink-on-the-pharmacokinetics-of-elvitegravir-cobicistat-emtricitabine-tenofovir-alafenamide-and-tenofovir-compared-with-a-standard-meal-in-healthy-japanese-male-subjects
#16
REVIEW
Hiroyuki Yamada, Ippei Ikushima, Takanori Nemoto, Tomohiro Ishikawa, Noriko Ninomiya, Shin Irie
This study investigated the effects of ingested meal types on the pharmacokinetics of elvitegravir (EVG), cobicistat (COBI), emtricitabine (FTC), tenofovir alafenamide (TAF), and tenofovir (TFV) following a single administration of the single-tablet regimen (STR) of EVG/COBI/FTC/TAF (150/150/200/10 mg) in Japanese HIV-negative healthy subjects (n = 12). In this open-label, randomized, 3-way crossover study, the bioequivalence of the EVG/COBI/FTC/TAF STR following ingestion of a nutritional protein-rich drink with a reference treatment of taking a standard breakfast was evaluated...
June 5, 2017: Clinical Pharmacology in Drug Development
https://www.readbyqxmd.com/read/28556598/single-and-multiple-day-dosing-studies-to-investigate-high-dose-pharmacokinetics-of-epelsiban-and-its-metabolite-gsk2395448-in-healthy-female-volunteers
#17
Kelly M Mahar, Mary Beth Enslin, Angie Gress, Heather Amrine-Madsen, Melisa Cooper
Open-label single- and double-blind repeat-dose studies in healthy female volunteers were conducted to investigate the pharmacokinetics (PK) and safety/tolerability of epelsiban total daily doses ranging from 600 to 900 mg. In 1 study (n = 12), epelsiban was dosed at 300 or 450 mg twice daily (every 12 hours) for a single day. In the repeat-dose double-blind study, epelsiban and placebo were administered to 31 subjects as 200 mg 3 times daily, 300 mg 3 times daily (TID), or 450 mg twice daily (BID) for 14 days...
May 26, 2017: Clinical Pharmacology in Drug Development
https://www.readbyqxmd.com/read/28544581/a-comparison-of-the-pharmacokinetics-of-methylphenidate-extended-release-orally-disintegrating-tablets-with-a-reference-extended-release-formulation-of-methylphenidate-in-healthy-adults
#18
Ann Childress, Jeffrey G Stark, Russ McMahen, Dorothy Engelking, Carolyn Sikes
Extended-release (ER) methylphenidate (MPH) is a first-line treatment for attention-deficit/hyperactivity disorder. A methylphenidate extended-release orally disintegrating tablet (MPH XR-ODT) has recently been developed. This was a randomized, open-label, 3-period, 3-treatment study comparing the bioavailability and absorption of 2 MPH XR-ODT formulations with an MPH ER reference medication. Here we report the 2 treatments comparing the commercial MPH XR-ODT formulation and reference medication. Following a ≥10-hour fast, 42 healthy adults received 60 mg of reference medication or MPH XR-ODT (2 × 30 mg)...
May 25, 2017: Clinical Pharmacology in Drug Development
https://www.readbyqxmd.com/read/28544344/fed-and-fasted-administration-of-a-novel-extended-release-methylphenidate-orally-disintegrating-tablet-formulation-for-the-treatment-of-adhd
#19
Richard H Weisler, Jeffrey G Stark, Carolyn Sikes
Extended-release methylphenidate is a first-line treatment for attention-deficit/hyperactivity disorder. A methylphenidate extended-release orally disintegrating tablet (MPH XR-ODT) has recently been developed. Here we report an open-label, randomized, 2-period, 2-treatment crossover study to determine the effect of food on the bioavailability of a single 60-mg dose of MPH XR-ODT in healthy adults. Blood samples were collected predose through 36 hours postdose. Maximum plasma concentration (Cmax ), time to maximum plasma concentration (Tmax ), terminal elimination half-life (T1/2 ), overall systemic exposure (AUClast and AUCinf ), and partial areas under the concentration curve (AUC0-3 , AUC3-7 , and AUC7-12 ) were calculated...
May 25, 2017: Clinical Pharmacology in Drug Development
https://www.readbyqxmd.com/read/27739230/safety-tolerability-and-pharmacokinetics-of-arc-520-injection-an-rna-interference-based-therapeutic-for-the-treatment-of-chronic-hepatitis-b-virus-infection-in-healthy-volunteers
#20
Thomas Schluep, Jason Lickliter, James Hamilton, David L Lewis, Ching-Lung Lai, Johnson Yn Lau, Stephen A Locarnini, Robert G Gish, Bruce D Given
ARC-520 Injection, an RNA interference drug for the treatment of hepatitis B that targets cccDNA-derived viral mRNA transcripts with high specificity, effectively reduces the production of viral proteins and HBV DNA. In this phase 1 randomized, double-blind, placebo-controlled study, 54 healthy volunteers (half male, half female) received a single, intravenous dose of 0.01-4.0 mg/kg ARC-520 Injection (n = 36) or placebo (n = 18). Assessments included safety, tolerability, pharmacokinetics, and pharmacodynamics (cytokines and complement)...
July 2017: Clinical Pharmacology in Drug Development
journal
journal
43835
1
2
Fetch more papers »
Fetching more papers... Fetching...
Read by QxMD. Sign in or create an account to discover new knowledge that matter to you.
Remove bar
Read by QxMD icon Read
×

Search Tips

Use Boolean operators: AND/OR

diabetic AND foot
diabetes OR diabetic

Exclude a word using the 'minus' sign

Virchow -triad

Use Parentheses

water AND (cup OR glass)

Add an asterisk (*) at end of a word to include word stems

Neuro* will search for Neurology, Neuroscientist, Neurological, and so on

Use quotes to search for an exact phrase

"primary prevention of cancer"
(heart or cardiac or cardio*) AND arrest -"American Heart Association"