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Bioequivalence Study of Empagliflozin 25 mg Film-coated Tablets in Healthy Thai Volunteers - Trial NCT06337409

Access comprehensive clinical trial information for NCT06337409 through Pure Global AI's free database. This Phase 1 trial is sponsored by International Bio service and is currently Not yet recruiting. The study focuses on Healthy Volunteer. Target enrollment is 30 participants.

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NCT06337409
Phase 1
Not yet recruiting
drug
Trial Details
ClinicalTrials.gov • NCT06337409
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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

Study Focus

Healthy Volunteer

Generic empagliflozin 25 mg film-coated tablets

Interventional

drug

Sponsor & Location

International Bio service

Timeline & Enrollment

Phase 1

Jul 01, 2024

Jul 13, 2024

30 participants

Primary Outcome

Bioequivalence based on Cmax period

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

ICD-10 Classifications

Healthy person accompanying sick person
Routine general health check-up of armed forces
Persons encountering health services in other circumstances
Persons encountering health services in other circumstances
Person encountering health services in unspecified circumstances

Data Source

ClinicalTrials.gov

NCT06337409

Non-Device Trial