Study of absorption and elimination rate of Biperiden 4-mg extended-release tablets in comparison with Biperiden brand tablets (Akineton®)
- Conditions
- Bioequivalence study.
- Registration Number
- IRCT20200407046981N44
- Lead Sponsor
- Vana Darou Gostar Pharmaceutical Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Male
- Target Recruitment
- 24
Healthy male volunteers in the age range of 18-60 years old
The weight limit of each volunteer should be between 60 and 100 kg.
Body mass index should be between18-30
All volunteers must be non-smokers
They must be healthy in terms of liver, kidney, respiratory system, mental and other general health characteristics that will be assessed
Candidates who have consented to the consent form
Known hypersensitivity or idiosyncratic reaction to Biperiden or any ingredients
Subjects with BP = 90/60 mm/Hg or BP = 140/90 mm/Hg
Taking any medicine during two week before dosing.
Any effects of renal, hepatic, cardiac, pulmonary or gastrointestinal dysfunction
Any history of tuberculosis, seizures, asthma, diabetes, insanity or glaucoma
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Peak Plasma Concentration (Cmax). Timepoint: 0 (before dosing), 1, 2, 3, 4, 6, 8, 10, 11, 12, 24, 36 and 48 hours after dosing. Method of measurement: High-performance liquid chromatography—mass spectrometry (HPLC-MS).
- Secondary Outcome Measures
Name Time Method AUC (Area Under the Concentration-Time Curve). Timepoint: 0 (before dosing), 1, 2, 3, 4, 6, 8, 10, 11, 12, 24, 36 and 48 hours after dosing. Method of measurement: Using non-compartmental model of Win-Nonlin Professional software version 3.2.A (Pharsight Corporation, USA) or SPSS.