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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)

NCT05491330 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2023-01-18

No results posted yet for this study

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)

Conditions

  • Healthy

Interventions

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

Sponsors & Collaborators

  • Eva Pharma

    collaborator INDUSTRY

  • Genuine Research Center, Egypt

    lead INDUSTRY

Principal Investigators

  • Ahmed Elshafeey, Ph.D. Pharma · Genuine Research Center

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-08-21
Primary Completion
2022-09-04
Completion
2022-10-27

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05491330 on ClinicalTrials.gov