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Bioequivalence study of Quintianex 200 mg slow-release tablets from Arang Daro Darman Pharmaceutical Company and its comparison with the brand product (Seroquel®) manufactured by AstraZeneca in healthy Iranian volunteers

Bioequivalence study of Quintianex 200 mg slow-release tablets from Arang Daro Darman Pharmaceutical Company and its comparison with the brand product (Seroquel®) manufactured by AstraZeneca in healthy Iranian volunteers

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
IRCT
Registry ID
IRCT20231108059993N3
Enrollment
24
Registered
2025-05-21
Start date
2025-06-14
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

The study uses healthy men volunteers aged 18-60..

Interventions

Intervention 1: The control group in this study is to investigate the bioequivalence of Quintianex 200 mg slow-release tablets manufactured by Arang Daro Darman Company. Intervention 2: The interventi

Sponsors

Arang Daroo Darman Pharmaceutical Company
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Have good general health (liver, heart, and kidneys). Body mass index is (18-28). Informed consent will be obtained. Ages are (18-60 years).

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Drug concentration. Timepoint: 14 sampling time included pre-dose (time 0) and at the following hours post-dose: 0/5, 1, 1/5, 2, 2/5, 3, 4, 5, 6, 7, 8, 10, and 12 h. Method of measurement: En Liquid Chromatography with tandem mass spectrometry (LC-MS-MS).—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSaeed Ghnbarzadeh

Tabriz University of Medical Sciences

s_ghanbarzadeh@yahoo.com+98 41 3383 2649

Outcome results

None listed

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