Bioequivalence study of Ibuprofen ER 800 mg
Not Applicable
- Conditions
- Bioequivalence study of Tablet Ibuprofen ER 800 mg (kimiara) versus Brufen® Retard (Abbott/UK pharmaceuticals) Tablet after single oral dosing in healthy volunteers.
- Registration Number
- IRCT20220111053692N13
- Lead Sponsor
- Kimiara Heram Pharmaceutical Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- 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
Any history of allergy to the drug or formulation components
Those with known history of drug abuse. alcohol consumer or cigarette smokers.
Taking medications that have drug interactions with Ibuprofen 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, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 Hours after the start of the intervention. Method of measurement: chromatography.
- Secondary Outcome Measures
Name Time Method