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Bioequivalence Study of Ribavirin in Healthy Adult Subjects Under Fed Condition

Healthy Subjects Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05532306
Study type Interventional
Source Future University in Egypt
Contact
Status Completed
Phase Phase 1
Start date October 11, 2020
Completion date November 23, 2020
View Details
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