NCT05532306

Bioequivalence Study of Ribavirin in Healthy Adult Subjects Under Fed Condition

A Randomized, Single Oral Dose, Two-way Crossover, Open-label, Laboratory Blind, Bioequivalence Study Comparing Ribavirin From Two Different Drug Products After Oral Administration to Healthy Adult Subjects Under Fed Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Future University in Egypt · Academic / Other
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

Enrolled subjects were randomized in a two-phase, two-sequence, cross-over design to receive a single dose of the test product (T) or the reference product (R) each phase, under fed conditions, with a wash-out period of 42 days. Ribavirin plasma concentration was determined using a validated LC-MS-MS method, followed by Pharmacokinetics, and statistical analysis using Phoenix WinNonlin® software to determine the average bioequivalence.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
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

Timeline

• Start date: 2020-10-11
• Primary completion: 2020-11-23
• Completion: 2020-11-23
• First posted: 2022-09-08
• Last updated: 2022-09-08

Locations

1 site across 1 country: Egypt