scholarly journals The Bioequivalence and Effect of Food on the Pharmacokinetics of a Fixed‐Dose Combination Tablet Containing Rosuvastatin and Ezetimibe in Healthy Japanese Subjects

2019 ◽  
Vol 12 (6) ◽  
pp. 704-712
Author(s):  
Chisato Nishida ◽  
Yuki Matsumoto ◽  
Katsukuni Fujimoto ◽  
Masayoshi Shirakawa ◽  
Rebecca Ellen Wrishko ◽  
...  
Keyword(s):  
Fixed Dose Combination ◽  
Fixed Dose ◽  
Combination Tablet ◽  
Effect Of Food ◽  
Dose Combination ◽  
Japanese Subjects

Effect of food on the pharmacokinetics of a vildagliptin/metformin (50/1000 mg) fixed-dose combination tablet in healthy volunteers

2008 ◽  
Vol 24 (6) ◽  
pp. 1703-1709 ◽  
Author(s):  
Yan-Ling He ◽  
Brian Flannery ◽  
Joelle Campestrini ◽  
Selene Leon ◽  
Miguel A. Zinny ◽  
...  
Keyword(s):  
Healthy Volunteers ◽  
Fixed Dose Combination ◽  
Fixed Dose ◽  
Combination Tablet ◽  
Effect Of Food ◽  
Dose Combination

Oral Antidiabetic Drugs: Effect of Food on Absorption of Pioglitazone and Metformin From a Fixed-Dose Combination Tablet

2007 ◽  
Vol 47 (1) ◽  
pp. 48-55 ◽  
Author(s):  
Aziz Karim ◽  
Margaret Slater ◽  
Dawn Bradford ◽  
Lisa Schwartz ◽  
Aziz Laurent
Keyword(s):  
Antidiabetic Drugs ◽  
Fixed Dose Combination ◽  
Fixed Dose ◽  
Oral Antidiabetic Drugs ◽  
Combination Tablet ◽  
Oral Antidiabetic ◽  
Effect Of Food ◽  
Dose Combination

Effect of food on the pharmacokinetics of canagliflozin/metformin (150/1,000 mg) immediate-release fixed-dose combination tablet in healthy participants

2015 ◽  
Vol 53 (03) ◽  
pp. 256-264 ◽  
Author(s):  
Joseph Murphy ◽  
Shean-Sheng Wang ◽  
Hans Stieltjes ◽  
Ewa Wajs ◽  
Damayanthi Devineni
Keyword(s):  
Immediate Release ◽  
Fixed Dose Combination ◽  
Fixed Dose ◽  
Combination Tablet ◽  
Effect Of Food ◽  
Dose Combination ◽  
Healthy Participants

Bioequivalence of a Dolutegravir, Abacavir, and Lamivudine Fixed-Dose Combination Tablet and the Effect of Food

2014 ◽  
Vol 66 (4) ◽  
pp. 393-398 ◽  
Author(s):  
Stephen Weller ◽  
Shuguang Chen ◽  
Julie Borland ◽  
Paul Savina ◽  
Brian Wynne ◽  
...  
Keyword(s):  
Fixed Dose Combination ◽  
Fixed Dose ◽  
Combination Tablet ◽  
Effect Of Food ◽  
Dose Combination

2P-0610 Effect of food on the biovailability of dual therapy: A fixed-dose combination tablet of amlodipine and atorvastatin

2003 ◽  
Vol 4 (2) ◽  
pp. 174 ◽  
Author(s):  
M. Chung ◽  
E. Randinitis ◽  
A. Calcagni ◽  
C. Bramson ◽  
P. Glue
Keyword(s):  
Dual Therapy ◽  
Fixed Dose Combination ◽  
Fixed Dose ◽  
Combination Tablet ◽  
Effect Of Food ◽  
Dose Combination

scholarly journals Bioequivalence of a Fixed-Dose Combination Tablet of the Complete Two-Drug Regimen of Dolutegravir and Rilpivirine for Treatment of HIV-1 Infection

2018 ◽  
Vol 62 (9) ◽  
Author(s):  
Rashmi Mehta ◽  
Allen Wolstenholme ◽  
Kristin Di Lullo ◽  
Caifeng Fu ◽  
Shashidhar Joshi ◽  
...  
Keyword(s):  
Statistical Power ◽  
Drug Regimen ◽  
Fixed Dose Combination ◽  
Fixed Dose ◽  
Combination Tablet ◽  
Reference Treatment ◽  
Dose Combination ◽  
Hiv 1 ◽  
Test Treatment ◽  
Separate Tablets

ABSTRACTA complete 2-drug regimen of dolutegravir at 50 mg and rilpivirine at 25 mg was approved to treat HIV-1 infection in virologically suppressed patients after demonstrating acceptable efficacy and tolerability. This study investigated the bioequivalence and pharmacokinetics of the fixed-dose combination tablet compared with those of separate tablets. Secondary endpoints were the tolerability and safety of the fixed-dose combination tablet. In this open-label, randomized-sequence, 2-way crossover trial, single doses of the fixed-dose combination tablet (the test treatment) and the combination of separate tablets (the reference treatment) were administered to healthy adults after a moderate-fat meal, with a 21-day washout between treatments. Pharmacokinetic samples were collected through 12 days after dosing. The primary endpoints were the area under the plasma concentration-time curve (AUC) and the maximum concentration of drug in plasma (Cmax). The study employed a prespecified sample size reestimation based on a blind midpoint review ofCmaxvariability to update the enrollment size to achieve statistical power. Of 118 participants enrolled, 113 received both treatments and underwent pharmacokinetic assessment. The 90% confidence intervals for the geometric least-squares mean ratios for the AUC from 0 h to infinity, the AUC from 0 h to the last quantifiable measurement, andCmax(test treatment versus reference treatment) were within the bioequivalence range of 0.80 to 1.25 for both drugs, indicating bioequivalence. In this study, a single dose of either treatment was well tolerated overall, with 4% (n= 5) and 3% (n= 3) of participants reporting adverse events considered related to the test and reference treatments, respectively. The dolutegravir-rilpivirine fixed-dose combination tablet is bioequivalent to a combination of separate tablets, and no new safety signals emerged. (This study has been registered at ClinicalTrials.gov under identifier NCT02741557.)

scholarly journals Design of Experiments for Wet Granulation of Valsartan and Pravastatin Fixed-Dose Combination Tablet

2016 ◽  
Vol 28 (12) ◽  
pp. 2759-2763
Author(s):  
Kang-Min Kim ◽  
Geun-Tae Kim ◽  
Jae-Seon Kang
Keyword(s):  
Design Of Experiments ◽  
Fixed Dose Combination ◽  
Fixed Dose ◽  
Wet Granulation ◽  
Combination Tablet ◽  
Dose Combination

Effect of food on the oral bioavailability of amlodipine/valsartan and amlodipine/valsartan/hydrochlorothiazide fixed dose combination tablets in healthy subjects

2014 ◽  
Vol 3 (6) ◽  
pp. 487-492 ◽  
Author(s):  
Gangadhar Sunkara ◽  
Xuemin Jiang ◽  
Christine Reynolds ◽  
Denise Serra ◽  
Yiming Zhang ◽  
...  
Keyword(s):  
Oral Bioavailability ◽  
Healthy Subjects ◽  
Fixed Dose Combination ◽  
Fixed Dose ◽  
Effect Of Food ◽  
Dose Combination
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