Bioequivalence study of zolpidem 10 mg tablet in 24 healthy male under fasting conditions
- Conditions
- comparative bioequivalence study of zolpidem 10 mg tablets of Marhamdarou Co. and Sanofi Co..
- Registration Number
- IRCT20180620040164N1
- Lead Sponsor
- Marham daru
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Male
- Target Recruitment
- 24
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
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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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).