Comparative randomized, single dose, three-way, three-sequence, two treatment, partial replicate, crossover, open-label study to determine the bioequivalence of Nirmatrelvir \& Ritonavir From Copaxid 150 +100 mg Tablets (Eva Pharma, Egypt) Versus Paxlovid 150 + 100 mg Film Coated Tablets (Pfizer Europe, Belgium)
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
Purpose
OTHER
Masking
NONE
Enrollment
28
2 tablets from Nirmatrelvir 150 mg + 1 tablet from Ritonavir 100 mg
2 tablets from Nirmatrelvir 150 mg + 1 tablet from Ritonavir 100 mg
2 tablets from Nirmatrelvir 150 mg + 1 tablet from Ritonavir 100 mg
Genuine Research Center GRC
Cairo, Egypt
Cmax
Maximal measured plasma concentration
Time frame: Up to 48 hours post dose in each treatment period
Time of the maximum plasma concentration (Tmax)
The amount of time that a drug is present at the maximum concentration in serum
Time frame: Up to 48 hours post dose in each treatment period
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