Bioequivalence Study of desloratadine 5 mg manufactured by Pharma Chemi and Clarinex manufactured by Schering
Not Applicable
- Conditions
- A crossover bioequivalence study in 24 healthy volunteers.
- Registration Number
- IRCT20220209053979N7
- Lead Sponsor
- Pharmachemi Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
Healthy male or female volunteers between the age of 18 and 55 with a body mass index (BMI) between 19 and 30
volunteers who are willing to sign an informed consent form
Exclusion Criteria
History of allergy to desloratadine or formulation components
History or significant clinical evidence of any disease
Taking any type of medicine in the 14 days before the start of the study
Participation in any clinical study within 30 days prior to study initiation
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, 0,5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 24, 48, 72 hours after drug administration. Method of measurement: Liquid chromatography with mass spectrophotometry.
- Secondary Outcome Measures
Name Time Method