Bioequivalence study of single dose of Sitagliptin 50mg tablet produced by Arya Pharm Co., IRAN

A non blind, randomized, open label, two treatments, single dose, crossover, bioequivalence study of Sitagliptin 50mg tablet of Arya Pharm Co., IRAN in comparison with Januvia tablet of MSD in 24 healthy adult subjects under fasting condition

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20190706044111N17

Enrollment

Registered

2020-03-25

Start date

2020-05-21

Completion date

Unknown

Last updated

2020-04-21

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

Conditions

Diabetes Mellitus. Type 2 diabetes mellitus

Interventions

Intervention 1: Intervention group: Sitagliptine, two 50mg tablets, produced by Arya Pharm Co (IRAN), single dose. Intervention 2: Control group: Januvia, one 100mg tablet, produced by MSD company,

Eligibility

Sex/Gender

All

Age

18 Years to 50 Years

Inclusion criteria

Inclusion criteria: Aged between 18 - 50 years Body weight between 50 – 100 kg Having good health based on medical history and physical & clinical examination Understand the procedures and give written informed consent

Exclusion criteria

Exclusion criteria: Subject who has showed clinically relevant deviations from normal in physical examination (BMI less than 18 & more than 30, ...) Subject has undergone surgery of the gastro-intestinal tract Subject had donated a unit of blood or participated in another clinical trial, within the last 3 months before the first treatment Subject had a history of drug or alcohol abuse Subject who smokes more than 10 cigarettes per day Subject has used any prescribed medication within last 14 days, or any non-prescribed medication within 7 days, before the first treatment

Design outcomes

Primary

Measure	Time frame
Plasma concentration of sitagliptin. Timepoint: At 0 (before prescription), 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 7.0, 8.0, 10.0, 24.0 & 36.0 hours after drug administration. Method of measurement: High Performance Liquid Chromatography (HPLC).	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactLadan Tayebi

Pars Biopharmacy Research company

l.tayebi@parsbiopharmacy.com+98 21 8895 6061

Outcome results

None listed

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