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
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Enrollment
24
1 tablet contains 60 mg Daclatasvir
1 tablet contains 60 mg Daclatasvir
Genuine Research Center GRC
Cairo, Egypt
Maximal measured plasma concentration (Cmax)
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
Time frame: Up to 72 hours post dose in each treatment period
Time of the maximum plasma concentration (Tmax)
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
Time frame: Up to 72 hours post dose in each treatment period
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.