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

NCT06243809 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2024-02-07

No results posted yet for this study

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

Conditions

  • Healthy Volunteer

Interventions

DRUG

Linagliptin 5 mg Oral Tablet

Linagliptin 5 mg Oral Tablet

DRUG

Trajenta 5 MG Oral Tablet

Linagliptin 5 mg Oral Tablet (Trajenta )

Sponsors & Collaborators

  • International Bio service

    lead NETWORK

Principal Investigators

  • Uthai Suvanakoot · International Bio service

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-04-24
Primary Completion
2024-05-10
Completion
2024-07-02

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06243809 on ClinicalTrials.gov