View clinical trials related to Bioequivalence Study.
Filter by:This is a single-dose, two-periods, two-sequence, two-way crossover, single oral dose bioequivalence study.
This is An Open Label, Randomized, Single Dose, Two Way Cross over, Two Period, Two Treatment, Two Sequence Bioequivalence Study to compare the rate and extent of absorption of Klaribact FC Tablet (Clarithromycin 500 mg) with Reference Product, Klaricid FC Tablet (Clarithromycin 500 mg) in healthy adult male subjects under fasting condition.
Single oral dose of study drug in two period(s) separated by a washout period of seven (07) days. Blood samples will be taken up to 24.0 hours post-dose.
Single oral dose, of test and reference Tablet will be administered to healthy volunteers, after at least 10 hours fast together with 240 mL of ambient temperature water at their scheduled dosing time-points. Blood samples will be taken up to 72.0 hours post-dose.
Study Objectives Primary To evaluate the average bioequivalence in healthy volunteers between medicinal product of Diclofenac Sodium 140mg Medicated Plaster EQI7 in comparison to the reference medicinal product Flector®, applied once and twice a day. Secondary To evaluate pharmacokinetic profile on Day 1, adhesivity, local tolerability and safety of medicinal product Diclofenac Sodium 140mg Medicated Plaster EQI7 in healthy volunteers in comparison to the reference medicinal product Flector®, applied once and twice a day.
To compare pharmacodynamic vasoconstriction response profile of Clocortolone Pivalate 0.1% Cream and Cloderm® (Clocortolone Pivalate) 0.1% Cream in normal skin of healthy male and female adults
The purpose of this study is to evaluate the bioequivalece of NPC-12 granules in compare with NPC-12T tablets in Japanese healthy Adults
In a phase 1, open-label, crossover study to evaluate the relative bioavailability of a tablet formulation of ravidasvir (test) versus the capsule formulation of ravidasvir (reference) in 24 healthy adult volunteers (PPI-668-104 study), relatively high intra-subject coefficients of variation were observed for both Cmax and AUC0-t. A two-sequence, four-period replicate design will be used to allow the possibility to scale the acceptance range for Cmax if the observed intra-subject coefficient of variation for the reference formulation is greater than 30%
The study design is an Open-Label，Randomized, Single-Dose, 2-way Crossover Bioequivalence Study. During each session, the subjects will be administered a single dose of 250mg Gefitinib Tablet (one Gefitinib Tablet 250mg of Hunan Kelun or one Iressa® Tablet 250mg of AstraZeneca) under fasting conditions.
This study is to investigate whether D961H sachet 20 mg is bioequivalent to D961H HPMC capsule 20 mg following repeated oral doses, and to evaluate the safety and tolerability of these two formulations in healthy male Japanese subjects.