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Bioequivalence study of Prazosin 5mg tablet of Amin Pharm Co., IRAN

A randomized, open label, single dose, crossover, bioequivalence study of Prazosin 5mg tablet produced by Amin Pharm Co., IRAN in comparison owith MiniPress 5mg tablet produced by Laphal Co. in 24 healthy adult subjects under fasting condition

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
IRCT
Registry ID
IRCT20190706044111N27
Enrollment
24
Registered
2022-01-12
Start date
2022-04-20
Completion date
Unknown
Last updated
2022-02-07

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

Conditions

Hypertension. Essential (primary) hypertension

Interventions

Intervention 1: Intervention group: Prazosin, one 5mg tablet, produced by Amin Pharm Co. (IRAN), single dose. Intervention 2: Control group: MiniPress, one 5mg tablet, produced by Laphal company, sing

Sponsors

Amin Pharm. Co.
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: Aged between 18 - 50 years Body weight between 50 – 100 kg Having good health on the basis of medical history and physical & clinical examination Understand the procedures and give written informed consent

Exclusion criteria

Exclusion criteria: History of the gastro-intestinal tract surgery Subject with a history of blood donation or participation in another clinical trial, within the last two months before the first treatment Subject with a history of drug or alcohol abuse. Subject who smokes more than 10 cigarettes per day. Subject with a history of disease leading to using drug within 14 days, or any non-prescription medication within 7 days, before the first treatment.

Design outcomes

Primary

MeasureTime frame
Plasma concentration of prazosin after single dose of 5mg prazosin tablet. Timepoint: at 0 (before dosing), 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0 & 10.0 hr. after dosing. Method of measurement: High Performance Liquid Chromatography (HPLC).

Countries

Iran (Islamic Republic of)

Contacts

Public ContactLadan Tayebi

Pars Biopharmacy Research Co.

l.tayebi@parsbiopharmacy.com+98 21 8895 6061

Outcome results

None listed

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