NCT06337409

Bioequivalence Study of Empagliflozin 25 mg Film-coated Tablets in Healthy Thai Volunteers

A Single Dose, Randomized, Open-label, Two-way Crossover Bioequivalence Study of Generic Empagliflozin 25 mg Film-coated Tablets and Reference Product (JARDIANCE®) in Healthy Thai Volunteers Under Fasting Conditions

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: International Bio service · Network
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

To determine and compare the rate and extent of absorption of a test formulation with that of a reference innovator formulation when given as equal labeled dose in healthy subjects 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.

Conditions

• Healthy Volunteer

Interventions

Type	Name	Description
DRUG	Generic empagliflozin 25 mg film-coated tablets	Empagliflozin 25 mg film-coated tablets

Timeline

• Start date: 2024-07-01
• Primary completion: 2024-07-05
• Completion: 2024-07-13
• First posted: 2024-03-29
• Last updated: 2024-04-02