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
Trial Snapshot
- Phase
- Phase 1
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 48
- Primary Endpoint
- Plasma Area Under the Curve (AUC(0 to 72hr)) for Linagliptin
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Linagliptin 5 mg, Then Trajenta 5 mg
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.
Intervention: Linagliptin 5 mg Oral Tablet (Drug)
Linagliptin 5 mg, Then Trajenta 5 mg
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.
Intervention: Trajenta 5 MG Oral Tablet (Drug)
Trajenta 5 mg, Then Linagliptin 5 mg
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
Intervention: Linagliptin 5 mg Oral Tablet (Drug)
Trajenta 5 mg, Then Linagliptin 5 mg
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
Intervention: Trajenta 5 MG Oral Tablet (Drug)
Outcomes
Primary Outcomes
Plasma Area Under the Curve (AUC(0 to 72hr)) for Linagliptin
Time Frame: Through 72 Hours Post Dose
Plasma Area Under the Curve of Linagliptin
Peak Plasma Concentration (Cmax) of Linagliptin
Time Frame: 72 Hours Post Dose
Peak Plasma Concentration (Cmax) of Linagliptin
Secondary Outcomes
No secondary outcomes reported