Bioequivalence study of Sitagliptin 50mg tablet of Alborzdarou Pharm Co., IRAN

A randomized, open label, two treatment, two period, two sequence, single dose, crossover, bioequivalence study of Sitagliptin 50mg tablet of Alborzdarou Pharm Co., IRAN and Januvia 50mg tablet of MSD in 24 healthy adult subjects under fasting condition

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20190706044111N4

Enrollment

Registered

2019-08-25

Start date

2019-06-20

Completion date

Unknown

Last updated

2019-10-07

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

Conditions

None listed

Interventions

Intervention 1: Intervention group: Single oral dose of Sitagliptin 50mg * 2 tablets of Alborzdarou Pharm Co. Intervention 2: Control group: Single oral dose of Januvia 50mg * 2 tablets of MSD.

Eligibility

Sex/Gender

All

Age

20 Years to 50 Years

Inclusion criteria

Inclusion criteria: - Aged between 20 - 50 years - Body weight between 50 – 100 kg - Having good health on the basis of medical history and physical & clinical examination - Understand the procedures and give written informed consent

Exclusion criteria

Exclusion criteria: Subject showed clinically relevant deviations from normal in physical examination. Subject had undergone surgery of the gastro-intestinal tract Subject had donated a unit of blood or participated in another clinical trial, within the last tree months before the first treatment. Subject had a history of drug or alcohol abuse. Subject who smokes more than 10 cigarettes per day. Subject had used any prescription medication within 14 days, or any non-prescription medication within 7 days, before the first treatment. Subject had a history of allergic to this class of drugs

Design outcomes

Primary

Measure	Time frame
Plasma concentration of sitagliptine. Timepoint: 0 (before dosing), 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 10.0, 24.0 & 36.0 hr. post dose. Method of measurement: HPLC.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactLadan Tayebi

Pars Biopharmacy Research Co.

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

Outcome results