Relative Bioavailability and Pharmacokinetic Comparison of a Fixed‐Dose Combination Tablet of Mosapride, Pancreatin and Simethicone Relative to Single‐component Mosapride Tablets in Healthy Mexican Subjects

2021 ◽  
Author(s):  
Karen Paola Camarillo Cárdenas ◽  
Jessica García González ◽  
Federico Alberto Argüelles Tello ◽  
Jorge Arturo Ocampo Ramírez ◽  
José Belisario Moreno Hernández ◽  
...  
Keyword(s):  
Relative Bioavailability ◽  
Single Component ◽  
Fixed Dose Combination ◽  
Fixed Dose ◽  
Combination Tablet ◽  
Dose Combination

Relative bioavailability of an empagliflozin 25-mg/linagliptin 5-mg fixed-dose combination tablet

2017 ◽  
Vol 55 (04) ◽  
pp. 355-367 ◽  
Author(s):  
Stephan Glund ◽  
Michaela Mattheus ◽  
Frank Runge ◽  
Peter Rose ◽  
Christian Friedrich
Keyword(s):  
Relative Bioavailability ◽  
Fixed Dose Combination ◽  
Fixed Dose ◽  
Combination Tablet ◽  
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
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