Bioequivalence study of zolpidem 10 mg tablet in 24 healthy male under fasting conditions

Randomized, single-dose, crossover comparative bioavailability study of the Marhamdarou zolpidem versus Stilnoct (Sanofi Company) in 24 healthy males under fasting conditions

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20180620040164N1

Enrollment

Registered

2018-12-06

Start date

2018-01-18

Completion date

Unknown

Last updated

2019-01-14

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

Conditions

comparative bioequivalence study of zolpidem 10 mg tablets of Marhamdarou Co. and Sanofi Co..

Interventions

Intervention 1: Intervention group (Test): Zolpidem 10 mg Tablet, produced by Marham Darou is the test product. In each period, 12 of 24 subjects will be given single oral dose of this product. Interv

Eligibility

Sex/Gender

Male

Age

18 Years to 55 Years

Inclusion criteria

Inclusion criteria: healthy subjects with BMI 18.5-30 kg/m2 Not having a history of any significant disease or any abnormal finding in laboratory examination or during physical examination Not physical or psychological dependence to narcotics

Exclusion criteria

Exclusion criteria: Known hypersensitivity to zolpidem or any ingredients. Obstructive sleep apnea Ingestion of a medicine (even herbal medicines), drugs for abuse or cigarette at any time within 7 days before dosing in Period-I (before the beginning of the study) History of any problem in blood donation Consumption of alcohol, grapefruit juice or caffeinated drinks 24 hours prior to the drug administration. Myasthenia gravis Severe hepatic insufficiency Acute and/or severe respiratory depression Any diseases that interacting with ADME (Absorption, Distribution, Metabolism & Excretion) procedures Psychotic illnesses Blood loss (>200 ml) during recent 60 days

Design outcomes

Primary

Measure	Time frame
Peak Plasma Concentration (Cmax). Timepoint: During 2 months after intervention. Method of measurement: using non-compartmental model of Win-Nonlin Professional software version 3.2.A (Pharsight Corporation, USA).	—

Secondary

Measure	Time frame
Time of maximum measured plasma concentration (Tmax). Timepoint: During 2 months after intervention. Method of measurement: Using non-compartmental model of Win-Nonlin Professional software version 3.2.A (Pharsight Corporation, USA).	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAli Aghaei

Tavan Institute

info@tavaninstitute.ir+98 21 6600 4027

Outcome results

None listed

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