IRCT20201212049683N1Completed未知
Relative bioavailability comparison of Alprazolam 0.5mg tablet formulations in healthy adult male volunteers under fasting conditions
Raha Pharmaceutical Company0 sites24 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- 未知
- Status
- Completed
- Sponsor
- Enrollment
- 24
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 years to 50 years (—)
- Sex
- Male
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Investigators
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