Study of absorption and elimination rate of Palbociclib 125-mg Capsules in comparison with Palbociclib brand capsules (Ibrance®) .
Not Applicable
Recruiting
- Conditions
- bioequivalence study.
- Registration Number
- IRCT20200407046981N40
- Lead Sponsor
- Kimia pharmaceutical Co
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Male
- Target Recruitment
- 24
Inclusion Criteria
The weight limit of each volunteer should be between 60 and 100 kg.
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
Exclusion Criteria
Known hypersensitivity or idiosyncratic reaction to Palbociclib or any ingredients.
Subjects with BP = 90/60 mm/Hg or BP = 140/90 mm/Hg.
Regular smoker who smokes more than ten cigarettes daily.
Taking any medicine during two week before dosing.
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, 5, 6, 7, 8, 10, 12, 24, 48 and 72 hour 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, 5, 6, 7, 8, 10, 12, 24, 48 and 72 hour after dosing. Method of measurement: Using non-compartmental model of Win-Nonlin Professional software version 3.2.A (Pharsight Corporation, USA) or SPSS.