NCT06243809

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: International Bio service · Network
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Detailed description

The primary objective of this bioequivalence study is to assess and compare the rate and extent of absorption of a test formulation against a reference formulation, with an additional focus on evaluating the safety profiles of both formulations. This study aims to provide critical insights into the bioequivalence of the two formulations, shedding light on their pharmacokinetic parameters and overall safety in the context of therapeutic efficacy. Study Design: 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. The crossover design minimizes the impact of inter-individual variability, allowing for a more accurate assessment of the formulations' performance. Participant Selection: A total of 48 healthy Thai volunteers will be recruited to participate in the study. The inclusion criteria involve individuals who meet specific health standards and are willing to comply with the study requirements. The emphasis on recruiting healthy volunteers aims to establish a baseline for comparison, ensuring that any observed differences in absorption and safety can be attributed to the formulations under investigation. Study Conditions: The study will be conducted under fasting conditions to isolate the impact of the formulations on absorption without interference from food-related variables. Fasting conditions provide a controlled environment to evaluate the formulations' performance and allow for a more accurate determination of bioequivalence.

Conditions

• Healthy Volunteer

Interventions

Type	Name	Description
DRUG	Linagliptin 5 mg Oral Tablet	Linagliptin 5 mg Oral Tablet
DRUG	Trajenta 5 MG Oral Tablet	Linagliptin 5 mg Oral Tablet (Trajenta )

Timeline

• Start date: 2024-04-24
• Primary completion: 2024-05-10
• Completion: 2024-07-02
• First posted: 2024-02-06
• Last updated: 2024-02-07