Open Label, Randomized, Single Dose, Two-way Crossover 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)
Overview
- Phase
- Phase 1
- Intervention
- Prodactariv
- Conditions
- Healthy
- Sponsor
- Genuine Research Center, Egypt
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Maximal measured plasma concentration (Cmax)
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy male or female, age 18 to 55 years, inclusive.
- •Body weight within 15% of normal range according to the accepted normal values for body mass index (BMI).
- •Medical demographics without evidence of clinically significant deviation from normal medical condition.
- •Results of clinical laboratory test are within the normal range or with a deviation that is not considered clinically significant by principal investigator.
- •Subject does not have allergy to the drugs under investigation.
Exclusion Criteria
- •Subjects with known allergy to the products tested.
- •Subjects whose values of BMI were outside the accepted normal ranges.
- •Female subjects who were pregnant, nursing or taking birth control pills.
- •Medical demographics with evidence of clinically significant deviation from normal medical condition.
- •Results of laboratory tests which are clinically significant.
- •Acute infection within one week preceding first study drug administration.
- •History of drug or alcohol abuse.
- •Subject does not agree not to take any prescription or non-prescription drugs within two weeks before first study drug administration and until the end of the study.
- •Subject is on a special diet (for example subject is vegetarian).
- •Subject does not agree not to consume any beverages or foods containing methyl-xanthenes e.g. caffeine (coffee, tea, cola, chocolate etc.) 48 hours prior to the study administration of either study period until donating the last sample in each respective period.
Arms & Interventions
A Test
Test drug (Prodactariv)1 tablet contains 60 mg Daclatasvir
Intervention: Prodactariv
B Reference
Reference drug (Clatazev) 1 tablet contains 60 mg Daclatasvir
Intervention: Clatazev
Outcomes
Primary Outcomes
Maximal measured plasma concentration (Cmax)
Time Frame: 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
Secondary Outcomes
- Time of the maximum plasma concentration (Tmax)(Up to 72 hours post dose in each treatment period)