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The Bioequivalence Study of Linagliptin 5 mg Film-coated Tablet in Healthy Thai Volunteers - Trial NCT06243809

Access comprehensive clinical trial information for NCT06243809 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 48 participants.

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NCT06243809
Phase 1
Not yet recruiting
drug
Trial Details
ClinicalTrials.gov • NCT06243809
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The Bioequivalence Study of Linagliptin 5 mg Film-coated Tablet in Healthy Thai Volunteers
A Single Dose, Randomized, Open-label, Two-way Crossover Bioequivalence Study of Generic Linagliptin 5 mg Film-coated Tablets (LINIPTIN) and Reference Product (Trajenta®) in Healthy Thai Volunteers Under Fasting Conditions

Study Focus

Healthy Volunteer

Linagliptin 5 mg Oral Tablet

Interventional

drug

Sponsor & Location

International Bio service

Timeline & Enrollment

Phase 1

Apr 24, 2024

Jul 02, 2024

48 participants

Primary Outcome

Plasma Area Under the Curve (AUC(0 to 72hr)) for Linagliptin,Peak Plasma Concentration (Cmax) of Linagliptin

Summary

A Single Dose, Randomized, Open-label, Two-way Crossover Bioequivalence Study of Generic
 Linagliptin 5 mg Film-coated Tablet (LINIPTIN) and Reference Product (Trajenta®) in Healthy
 Thai Volunteers 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

NCT06243809

Non-Device Trial