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

Phase 1

Not yet recruiting

• Conditions: Healthy Volunteer
• Interventions: Drug: Linagliptin 5 mg Oral Tablet; Drug: Trajenta 5 MG Oral Tablet

• Registration Number: NCT06243809
• Lead Sponsor: International Bio service

Brief 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.

Study Timeline

• Status Verified: 2023-12
• Study First Submitted: 2024-01-18
• Study First Submitted QC: 2024-01-28
• Last Update Submitted: 2024-02-05
• Study First Posted: 2024-02-06
• Last Update Posted: 2024-02-07
• Study Start: 2024-04-24
• Primary Completion: 2024-05-10
• Study Completion: 2024-07-02

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Linagliptin 5 mg, Then Trajenta 5 mg	Linagliptin 5 mg Oral Tablet	Participants first received Linagliptin 5 mg tablet 1 tablet (Test product) in a fasting state. After a washout period of 1 week, they then received Trajecta 5 mg tablet (Reference product) in a fasting state.
Linagliptin 5 mg, Then Trajenta 5 mg	Trajenta 5 MG Oral Tablet	Participants first received Linagliptin 5 mg tablet 1 tablet (Test product) in a fasting state. After a washout period of 1 week, they then received Trajecta 5 mg tablet (Reference product) in a fasting state.
Trajenta 5 mg, Then Linagliptin 5 mg	Trajenta 5 MG Oral Tablet	Participants first received Trajenta 5 mg tablet 1 tablet (Reference product) in a fasting state. After a washout period of 1 week, they then recieved Linagliptin 5 mg tablet (Test product) in a fasting state
Trajenta 5 mg, Then Linagliptin 5 mg	Linagliptin 5 mg Oral Tablet	Participants first received Trajenta 5 mg tablet 1 tablet (Reference product) in a fasting state. After a washout period of 1 week, they then recieved Linagliptin 5 mg tablet (Test product) in a fasting state

Primary Outcome Measures

Name	Time	Method
Plasma Area Under the Curve (AUC(0 to 72hr)) for Linagliptin	Through 72 Hours Post Dose	Plasma Area Under the Curve of Linagliptin
Peak Plasma Concentration (Cmax) of Linagliptin	72 Hours Post Dose	Peak Plasma Concentration (Cmax) of Linagliptin