Ligagliptin tablets 5mg ABIDI Pharmaceuticals (TRAJENTA® 5mg Tab) , In- Vivo Bioequivalence in Iranian healthy volunteers.

In- Vivo Bioequivalence study of Ligagliptin tablets 5mg (ABIDI Pharmaceuticals, Iran) with brand drug (TRAJENTA® 5mg Boehringer Ingelheim, Germany) in Iranian healthy volunteers.

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20200105046010N8

Enrollment

Registered

2020-08-31

Start date

2020-10-05

Completion date

Unknown

Last updated

2020-09-07

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

Conditions

In this study the bioquivalence of test and brand of Ligagliptin tablets 5mg will evaluated..

Interventions

Intervention 1: Intervention group: Single dose of 5 mg Linagliptine tablets (TRAJENTA® 5mg Boehringer Ingelheim, Germany) Pharmaceutical Company as a reference product. Intervention 2: Intervention g

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: General health(liver, heart, kidney) Body mass index(18-28) Informed consent Age(18-60)

Exclusion criteria

Exclusion criteria: Smoking A history of cardiovascular disease A history of liver & kidney disease Pregnancy Alcohol & Drug addiction Hypersensitivity to the drug

Design outcomes

Primary

Measure	Time frame
Drug analysis in plasma or whole blood. Timepoint: After blood sampling. Method of measurement: HPLC,LC-MS/MS or UPLC-MS/MS.	—

Secondary

Measure	Time frame
Pharmacokinetic parameters. Timepoint: Immediately after the intervention. Method of measurement: Theoretically and using pharmacokinetic equations.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactJavad Shokri

Tabriz University of Medical Sciences

Shokri.j@gmail.com+98 41 3334 8489

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026