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Bioequivalence Study of Daclatasvir From Prodactariv 60 mg Film Coated Tablets (International Drug Agency for Pharmaceutical Industry (IDI), Egypt) and Clatazev 60 mg Tablets (Bristol-Myers Squibb Pharma, UK)
NCT02780362
PHASE1INTERVENTIONAL
Genuine Research Center, Egypt
24 participants
Started 2016-04 · Completed 2016-04
Status: Completed (as of 12-23-2025)
Conditions
Healthy
Interventions
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3Total Citations Per Year
Brief Summary
An open label randomized, single dose, two-way crossover bioequivalence study to determine the bioequivalence of Daclatasvir from Prodactariv 60 mg F.C.T (International Drug Agency for Pharmaceutical Industry (IDI), Egypt) and Clatazev 60 mg F.C.T (Bristol-Myers Squibb Pharma, UK) in Healthy Human Volunteers Under Fasting Condition
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A comparison of the Two One-Sided Tests Procedure and the Power Approach for assessing the equivalence of average bioavailability
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Sample size determination for bioequivalence assessment by means of confidence intervals.
1991
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On sample size calculation in bioequivalence trials.
2001
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