NCT06228430

The Bioequivalence Study of Acyclovir 800 mg Tablet in Healthy Thai Volunteers Under Fasting Conditions

A Single Dose, Randomized, Open-label, Two-way Crossover Bioequivalence Study of Generic Acyclovir 800 mg Tablet and Reference Product (ZoviraxTM) in Healthy Thai Volunteers Under Fasting Conditions

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: International Bio service · Network
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

A Single Dose, Randomized, Open-label, Two-way Crossover Bioequivalence Study of Generic Acyclovir 800 mg Tablet and Reference Product (Zovirax™) in Healthy Thai Volunteers under Fasting Conditions

Detailed description

This study is conducted to investigate bioequivalence information which is required to ensure therapeutic equivalence of a test product and a reference product as well as to be considered as one aspect of product quality. Bioequivalence is defined as the absence of a significant difference in the rate and extent to which the active ingredient or active moiety in pharmaceutical equivalents or pharmaceutical alternatives becomes available at the site of drug action when administered at the same molar dose under similar conditions in an appropriately designed study. The manufacturer in Thailand needs to formulate a generic acyclovir 800 mg tablet. This study has been planned to evaluate the pharmacokinetics of this formulation and determine its bioequivalence with the reference product, Zovirax™, at the same dose.

Conditions

• Healthy Volunteer

Interventions

Type	Name	Description
DRUG	Acyclovir 800 mg Tablet	Acyclovir 800 mg Tablet (Test Drug)
DRUG	Zovirax™ 800 mg Tablet	Zovirax™ 800 mg Tablet (Reference Drug)

Timeline

• Start date: 2024-02-12
• Primary completion: 2024-02-15
• Completion: 2024-02-22
• First posted: 2024-01-29
• Last updated: 2024-01-29