In-vivo Bioequivalence Study of Montelukast 5 mg chewable tablets and 10 mg FC. tablets (Faran Shimi, Iran)

In-vivo Bioequivalence Study of Montelukast 5 mg chewable tablets and 10 mg FC. tablets (Faran Shimi, Iran) With Brand Drug (SINGULAIR® 5 mg chewable Tab. & 10 mg FC Tab., MSD Pharma, Germany) in Iranian Healthy Volunteers

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20200105046010N104

Enrollment

Registered

2024-06-16

Start date

2024-06-21

Completion date

Unknown

Last updated

2024-06-24

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

Conditions

This study is performed on healthy volunteers and drug concentration in plasma is determined..

Interventions

Intervention 1: Intervention group: Intervention group:Single dose, one oral The Reference Drug (SINGULAIR® 5 mg Merch Sharp & Dohme, MSD, Germany). after washout period, the volunteers receive Montel

Eligibility

Sex/Gender

All

Age

18 Years to 55 Years

Inclusion criteria

Inclusion criteria: General Health (Liver, Heart, and Kidney) Body Mass Index 18-28 kg/m^2 consentAge of 18-55 years old Informed consent

Exclusion criteria

Exclusion criteria: Nicotine consumption history Cardiovascular disease History Liver and kidney HistoryAlcohol and opioid addiction Allergy reactions history to Montelukast

Design outcomes

Primary

Measure	Time frame
Drug plasma concentration. Timepoint: -0, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 10, 24h after drug administration. Method of measurement: Liquid Chromatography Mass-Mass.	—

Secondary

Measure	Time frame
Time to reach maximum plasma concentration. Timepoint: After intervention. Method of measurement: Time to reach the maximum drug concentration in plasma is recorded.;Extent of absorption. Timepoint: After intervention. Method of measurement: Calculation of area under curve of concentration -time.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactJavad Shokri

Tabriz University of Medical Sciences

shokri.j@gmail.com+98 41 3661 4125

Outcome results

None listed

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