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.

NCT02756936 Phase 1 COMPLETED

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

Details

Lead sponsor	Genuine Research Center, Egypt
Phase	Phase 1
Status	COMPLETED
Enrolment	24
Start date	2016-02
Completion	2016-03

Conditions

• Healthy

Interventions

• Daclatasvir Zeta
• Clatazev

Primary outcomes

• Maximal measured plasma concentration (Cmax) — Up to 72 hours post dose in each treatment period
  Serial blood samples for determination of study drug will be collected at 0.00, 0.50, 1.00, 1.25, 1.50, 1.75, 2.00, 2.25, 2.50, 3.00, 3.50, 4.00, 6.00, 8.00, 12.00, 16.00, 24.00, 48.00, 72.00 hrs

Countries

Egypt