Bioequivalence study of Bicalutomide 50 mg
Not Applicable
- Conditions
- Bioequivalence study of Bicalutomide 50 mg tablet (Iran Hormone) versus Casodex® 50 mg (AstraZeneca-Brand) Tablet in healthy volunteers.
- Registration Number
- IRCT20220111053692N15
- Lead Sponsor
- Iran Hormone pharmaceutical Co.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Male
- Target Recruitment
- 24
Inclusion Criteria
18 to 55 years old
Weight in range of 10 % proper body weight
All volunteers should be in a good health condition on the basis of medical history ,physical examination , routine blood test.
Possessing negative test for hepatitis B surface antigen (HBs-Ag), Antihepatitis-C antibody (anti-HCV) and anti-HIV.
Gender: male
Exclusion Criteria
Volunteers with hypersensitivity to Bicalutomide were excluded.
Those with known history of drug abuse. alcohol consumer or cigarette smokers.
Taking medications that have drug interactions with Bicalutomide until one month before studying.
Disinclination to take the test
Blood donation or blood loss of more than 200 ml in the past month
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Drug concentration in plasma samples. Timepoint: In times 0, 1, 2, 3, 5, 7, 9, 12, 15, 24, 36, 48, 72, 168, 336, 504, 672 Hours after the start of the intervention. Method of measurement: chromatography.
- Secondary Outcome Measures
Name Time Method