NCT06243809

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

Name: Clinical Trial NCT06243809
Creator: International Bio service
Keywords: Healthy Volunteer, Linagliptin 5 mg Oral Tablet, Phase 1, drug, clinical trial

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

International Bio service·Phase 1·ClinicalTrials.gov·drugNot yet recruiting

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Study focus

Disease/Condition: Healthy Volunteer
Drug/Device/Intervention: Linagliptin 5 mg Oral Tablet
Study type: Interventional
Intervention type: drug

Sponsor & location

Primary sponsor: International Bio service

Timeline & enrollment

Phase: Phase 1
Start date: Apr 24, 2024
End date: Jul 02, 2024
Enrollment: 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 personRoutine general health check-up of armed forcesPersons encountering health services in other circumstancesPersons encountering health services in other circumstancesPerson encountering health services in unspecified circumstances

Data source

Registry: ClinicalTrials.gov
Trial ID: NCT06243809
Type: Non-Device Trial

About this record

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.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.