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Bioequivalence Study of Daclatasvir From Daktavira 60 mg Film Coated Tablets ( European Egyptian Pharmaceutical Industries, Egypt) Versus Daklinza 60 mg Tablets (Bristol-Myers Squibb Pharma, UK)
NCT02675127
PHASE1INTERVENTIONAL
Genuine Research Center, Egypt
24 participants
Started 2015-12 · Completed 2015-12
Status: Completed (as of 12-23-2025)
Conditions
Healthy
Interventions
Linked Papers (from SciSciNet-V2)
Total Papers3
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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 Daktavira 60 mg film coated tablets ( European Egyptian Pharmaceutical Industries, Egypt) versus Daklinza 60 mg tablets (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
1987
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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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