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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)

2016-05-24 12:08:21 | BioPortfolio

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

Description

Primary Pharmacokinetic Parameters: Cmax, AUC0→t and AUC0→∞ Secondary Pharmacokinetic Parameters: Ke, tmax and t1/2e. ANOVA using 5% significance level for transformed (with the 90% confidence intervals) and untransformed data of Cmax, AUC0→t and AUC0→∞ and for untransformed data of Ke, tmax and t1/2e.

The confidence intervals of logarithmically transformed Test/Reference ratios for Cmax, AUC0→t and AUC0→∞ to be within 80.00-125.00%.

A comprehensive final report will be issued upon the completion of the study.

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label

Conditions

Healthy

Intervention

Prodactariv, Clatazev

Location

Genuine Research Center GRC
Cairo
Egypt
11757

Status

Completed

Source

Genuine Research Center, Egypt

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-05-24T12:08:21-0400

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