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A Single Dose, Randomized, Open-label, Two-way Crossover Bioequivalence Study of Generic Linagliptin 5 mg Film-coated Tablets (LEZIGA) and Reference Product (Trajenta) in Healthy Thai Volunteers under Fasting Conditions

A Single Dose, Randomized, Open-label, Two-way Crossover Bioequivalence Study of Generic Linagliptin 5 mg Film-coated Tablets (LEZIGA) and Reference Product (Trajenta) in Healthy Thai Volunteers under Fasting Conditions

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
TCTR
Registry ID
TCTR20221031003
Enrollment
48
Registered
2022-10-31
Start date
2023-04-24
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Thai Volunteers Healthy Thai Volunteers

Interventions

Reference Product, Linagliptin 5 mg film-coated tablet, will be given orally with 240 mL of ambient temperature drinking water. No water and food for 1 hour and 4 hours, respectively, after dosing. Fi
Active Comparator Drug,Experimental Drug
Reference Product,Test Product

Sponsors

MacroPhar Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 55 Years

Inclusion criteria

Inclusion criteria: Healthy Thai Volunteers

Exclusion criteria

Exclusion criteria: 1 History of alleric reaction or hypersensitivity to linagliptin 2 History or evidence of clinically significant renal, hepatic, GI, hematological, endocrine, pulmonary or respiratory, cardiovascular, psychiatric, neurologic, allergic disease or any significant ongoing chronic medical illness. 3 Have high risk for COVID-19 or diagnosed as confirmed case of COVID-19

Design outcomes

Primary

MeasureTime frame
PK parameters 0.00 (pre-dose) and at 0.16, 0.33, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.33, 2.67, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 12.00, 24.00, 48.00 and 72.00 hours post-dose. Phoenix WinNonlin software, Version 8.3 or above—

Secondary

MeasureTime frame
Cmax 0.00 (pre-dose) and at 0.16, 0.33, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.33, 2.67, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 12.00, 24.00, 48.00 and 72.00 hours post-dose. Phoenix WinNonlin software, Version 8.3 or above—

Countries

Thailand

Contacts

Public ContactKitsana Poopanit Upatum

International Bio Service Co., Ltd.

kitsana.poo@mahidol.ac.th6624425211

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026