Bioequivalence study of methylphenidate hydrochloride 10 mg tablet
Not Applicable
Recruiting
- Conditions
- ---.
- Registration Number
- IRCT20230222057495N15
- Lead Sponsor
- Jalinous Pharmaceutical Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
Healthy volunteer between 18 and 55 years old.
Body mass index less than 30 kg per square meter.
All candidates must be non-smokers.
Exclusion Criteria
Blood pressure less than 90 on 60 mm Hg or more than 140 on 90 mm Hg.
Consumption of any drug, alcohol or tobacco within 2 weeks before receiving the drug.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The maximum plasma concentration of methylphenidate hydrochloride. Timepoint: before taking the drug and: 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 5, 6, 8 and 10 hours after taking the medicine. Method of measurement: Liquid chromatography-mass spectrometry.
- Secondary Outcome Measures
Name Time Method