NCT05491330

Bioequivalence Study of Nirmatrelvir & Ritonavir From Copaxid 150 +100 mg Tablets (Eva Pharma, Egypt) Versus Paxlovid 150 + 100 mg Film Coated Tablets (Pfizer Europe, Belgium)

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)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Genuine Research Center, Egypt · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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)

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	Nirmatrelvir 150 mg + Ritonavir 100 mg (Reference first dose)	2 tablets from Nirmatrelvir 150 mg + 1 tablet from Ritonavir 100 mg
DRUG	Nirmatrelvir 150 mg + Ritonavir 100 mg (test)	2 tablets from Nirmatrelvir 150 mg + 1 tablet from Ritonavir 100 mg
DRUG	Nirmatrelvir 150 mg + Ritonavir 100 mg (Reference second dose)	2 tablets from Nirmatrelvir 150 mg + 1 tablet from Ritonavir 100 mg

Timeline

• Start date: 2022-08-21
• Primary completion: 2022-09-04
• Completion: 2022-10-27
• First posted: 2022-08-08
• Last updated: 2023-01-18

Locations

1 site across 1 country: Egypt