In-vivo Bioequivalence Study of Palbociclib 125 mg Hard Capsules of The Test Drug (PADENZA®, Abidi Pharma, Iran)
Not Applicable
Recruiting
- Conditions
- This study is performed on healthy volunteers and drug concentration in plasma is determined..
- Registration Number
- IRCT20200105046010N112
- Lead Sponsor
- Abidi Pharmaceutical Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
General Health (Liver, Heart, and Kidney)
Body Mass Index (18-30)
Informed consent
Age (18-55years old)
Exclusion Criteria
Smoking
History of cardiovascular disease
History of liver and kidney disease
Alcoholism and Narcoticism
History of allergy to Palbociclib
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Drug plasma concentration. Timepoint: 0? 1? 2 ?4? 6? 8? 10? 12? 24? 48, 72 h after drug administration. Method of measurement: Liquid Chromatography Mass-Mass.
- Secondary Outcome Measures
Name Time Method 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.