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Relative bioavailability comparison of Alprazolam 0.5mg tablet formulations

Relative bioavailability comparison of Alprazolam 0.5mg tablet formulations in healthy adult male volunteers under fasting conditions

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
IRCT
Registry ID
IRCT20201212049683N1
Enrollment
24
Registered
2021-01-03
Start date
2021-01-20
Completion date
Unknown
Last updated
2021-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Relative bioavailability.

Interventions

Intervention 1: Intervention group 1: Two tablets of Raha pharmaceutical company alprazolam 0.5 mg simultaneously. Intervention 2: Intervention group 2: Two tablets of Pfizer pharmaceutical company

Sponsors

Raha Pharmaceutical Company
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 50 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAkram Sharifian

Esfahan University of Medical Sciences

dash481@yahoo.com+98 31 3792 7117

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026