Relative bioavailability comparison of Alprazolam 0.5mg tablet formulations
- Conditions
- Relative bioavailability.
- Registration Number
- IRCT20201212049683N1
- Lead Sponsor
- Raha Pharmaceutical Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Male
- Target Recruitment
- 24
Gender: Male
Age between 18 and 50 years
The volenteer is willing to do the study and can sign and submit the informed consent form
The candidate is fully present during the study and according to the consent form, believes in and adheres to the implementation of the study protocol
Candidate must have a specific place of residence and a landline
Normal clinical and laboratory results
History of allergy or allergy to alprazolam
Any history of hypersensitivity or intolerance that, in the opinion of the researcher, reduces the safety of the study volunteers
Any history of chronic infectious disease, systemic defects, or organ dysfunction
Presence of gastrointestinal disease or a history of malabsorption in the last year
A history of a medical problem over the last year that required medication or hospitalization
Drugs that significantly induce or inhibit drug-metabolizing enzymes that be used within 30 days prior to administration
Receive any medication from previous research studies within 30 days prior to the current study
Donation or loss of significant amounts of blood (480 ml or more) within 30 days prior to current study
Smokers or addicts
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Comparison of Cmax, Tmax and AUC and comparison of blood profiles of the two drugs. Timepoint: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 24, 36h. Method of measurement: HPLC analysis.
- Secondary Outcome Measures
Name Time Method