The Bioequivalence Study of Acyclovir 800 mg Tablet in Healthy Thai Volunteers Under Fasting Conditions
- Conditions
- Healthy Volunteer
- Interventions
- Drug: Zovirax™ 800 mg Tablet
- Registration Number
- NCT06228430
- Lead Sponsor
- International Bio service
- Brief 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 40
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Acyclovir 800 mg (Test Drug) Acyclovir 800 mg Tablet Generic Acyclovir 800 mg Tablet ZoviraxTM 800 mg Tablet (Reference Drug) Acyclovir 800 mg Tablet ZoviraxTM 800 mg Tablet ZoviraxTM 800 mg Tablet (Reference Drug) Zovirax™ 800 mg Tablet ZoviraxTM 800 mg Tablet Acyclovir 800 mg (Test Drug) Zovirax™ 800 mg Tablet Generic Acyclovir 800 mg Tablet
- Primary Outcome Measures
Name Time Method Plasma Area Under the Curve (AUC(0 to 36 Hour)) for Acyclovir Through 36 Hours Post Dose Plasma Area Under the Curve of Acyclovir
Peak Plasma Concentration (Cmax) of Acyclovir 36 Hours Post Dose Peak Plasma Concentration (Cmax) for Acyclovir
- Secondary Outcome Measures
Name Time Method