Bioequivalence of sustained release Diclofenac 100 mg capsule manufactured by Tasinm Pharmaceutical and Diclofenac 100 mg capsule manufactured by Ratio pharm
Not Applicable
- Conditions
- A crossover bioequivalence study in 24 healthy volunteers.
- Registration Number
- IRCT20220209053979N12
- Lead Sponsor
- Tasnim Pharmaceutical
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
Healthy male or female volunteers
Body mass index (BMI) between 18 - 30
Volunteers who are willing to sign an informed consent form
Exclusion Criteria
History of allergic reaction to memantin or formulation components
Taking any type of medicine in the 14 days before the start of the study
Participation in any type of clinical study in the last month
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Plasma concentration time profile, maximum plasma concentration, AUC. Timepoint: 0 ? 1? 1.5 ? 2 ? 2.5 ? 3? 4? 5? 6 ? 8? 10, 24 h after drug administration. Method of measurement: Liquid chromatography with mass spectrophotometry.
- Secondary Outcome Measures
Name Time Method Calculation of pharmacokinetic parameters like Cmax, AUC of test and reference drug. Timepoint: Same as primary outcome. Method of measurement: Pharmacokientic parameters are calculated by excel.