Bioequivalence study of Montelukast 10mg tablet of Amin Pharm Co., IRAN

A randomized, open label, two treatments, two periods, single dose, crossover, bioequivalence study of Montelukast 10mg tablet of Amin Pharm Co., IRAN in comparison of Singulair 10mg tablet of MS&D in 24 healthy adult subjects under fasting condition

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20190706044111N13

Enrollment

Registered

2019-12-27

Start date

2019-12-22

Completion date

Unknown

Last updated

2020-01-13

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

Conditions

Asthma. Asthma

Interventions

Intervention 1: Intervention group: Single dose of Montelukast 10mg tablet of Amin Pharm Co., IRAN. Intervention 2: Control group: Single dose of Singulair 10mg tablet of MS&D.

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 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 three 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.

Design outcomes

Primary

Measure	Time frame
Plasma concentration of montelukast. Timepoint: At 0 (before dosing), 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 3.5, 4.0, 5.0, 6.0, 8.0, 10.0 & 24.0 hr. after dosing. 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

None listed

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