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Bioequivalence Study of Ribavirin in Healthy Adult Subjects Under Fed Condition

NCT05532306 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2022-09-08

No results posted yet for this study

Summary

To evaluate and compare the relative plasma bioavailability and therefore the bioequivalence of two different immediate release products each containing Ribavirin 400 mg, after administering a single oral dose, to healthy adult subjects under fed conditions.

Conditions

  • Healthy Subjects

Interventions

DRUG

Ribavirin 400 mg film coated tablet (1*400mg)

an immediate release film-coated tablet containing 400 mg Ribavirin

DRUG

Copegus® 200 mg film coated tablet (2*200mg)

an immediate release film-coated tablet containing 200 mg Ribavirin

Sponsors & Collaborators

  • Future University in Egypt

    lead OTHER

Principal Investigators

  • Hala Masoud, PhD · Future Research Center (FRC)

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2020-10-11
Primary Completion
2020-11-23
Completion
2020-11-23

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 NCT05532306 on ClinicalTrials.gov