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In vivo Bioequivalence study of Aspirin tablet

In vivo Bioequivalence study of Aspirin 81mg tablet manufactured by Aani Darman Pharmaceutical Co. Compared to innovator Product

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
IRCT
Registry ID
IRCT20220211053992N6
Enrollment
24
Registered
2023-01-09
Start date
2023-01-10
Completion date
Unknown
Last updated
2023-02-07

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

Conditions

In the present study, the products will be administered to healthy volunteers..

Interventions

Intervention 1: Intervention group: Intervention group will receive a single oral dose of test product (Aspirin 81mg sachet manufactured by Aani Darman Co., Iran) in fasted state. Blood samples will b

Sponsors

Tabriz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 59 Years

Inclusion criteria

Inclusion criteria: General Health (in terms of Liver, Heart and Kidney diseases) Age between 18 to 60 years

Exclusion criteria

Exclusion criteria: Smoking, History of cardiovascular, liver, and kidney disease Pregnancy Alcohol and drug addiction History of drug allergy

Design outcomes

Primary

MeasureTime frame
Plasma concentration of drug. Timepoint: 0.5-24 hours in predetermined time intervals after drug administration. Method of measurement: HPLC (High performance liquid chromatography).

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHadi Valizadeh

Tabriz University of Medical Sciences

valizadehh@gmail.com+98 41 3334 8801

Outcome results

None listed

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