NCT02756936

Bioequivalence Study of Daclatasvir From Daclatasvir Zeta 60 mg Film Coated Tablets (Zeta Pharm Pharmaceutical Industries, Egypt) and Clatazev 60 mg Tablets (Bristol-Myers Squibb Pharma, UK)

Open Label, Randomized, Single Dose, Two-way Crossover Bioequivalence Study of Daclatasvir From Daclatasvir Zeta 60 mg Film Coated Tablets (Zeta Pharm Pharmaceutical Industries, Egypt) and Clatazev 60 mg Tablets (Bristol-Myers Squibb Pharma, UK) in Healthy Human Volunteers Under Fasting Condition.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Genuine Research Center, Egypt · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

An open label randomized, single dose, two-way crossover bioequivalence study to determine the bioequivalence of Daclatasvir from Daclatasvir zeta 60 mg F.C.T ( Zeta Pharm Pharmaceutical Industries, Egypt) versus Clatazev 60 mg F.C.T (Bristol-Myers Squibb Pharma, UK) in Healthy Human Volunteers Under Fasting Condition

Detailed 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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Daclatasvir Zeta	1 tablet contains 60 mg Daclatasvir
DRUG	Clatazev	1 tablet contains 60 mg Daclatasvir

Timeline

• Start date: 2016-02-01
• Primary completion: 2016-02-01
• Completion: 2016-03-01
• First posted: 2016-04-29
• Last updated: 2017-02-28

Locations

1 site across 1 country: Egypt