In-vivo Bioequivalence Test of Dapoxetine tablet 30 mg Mofid Pharma with brand drug (PRILIGY® 30 mg Tab, Menarini, Italy)

In- Vivo Bioequivalence study of Dapoxetine tablet 30 mg Mofid Pharma (DAPROLONG® 30 mgTab, Mofid Pharma, Iran) with brand drugs (PRILIGY® 30 mg Tab, Menarini, Italy) in Iranian healthy volunteers.

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20200105046010N64

Enrollment

Registered

2022-06-27

Start date

2022-07-01

Completion date

Unknown

Last updated

2022-08-29

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

Conditions

Bio equivalence test.

Interventions

Intervention 1: Intervention group: One test tablet (Dapoxetine tablet 30 mg Mofid Pharma) will be received. Blood samples will be taken for 48 hours at the mentioned times after drug administration a

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: General health Body mass index between18-28 Informed consent Being at the age of 18-60 years old

Exclusion criteria

Exclusion criteria: Smoking A history of cardiovascular disease A history of liver & kidney disease Pregnancy Alcohol & Drug addiction Hypersensitivity to the drug

Design outcomes

Primary

Measure	Time frame
Plasma drug concentration. Timepoint: Sampling times in this study will be 0? 0.5? 1? 1.25? 1.5? 1.75? 2? 2.5? 3? 3.5? 4? 6? 10 .8? 12, 24,36,48 hours after prescribing the tablet. Method of measurement: High Performance Liquid Chromatography with tandem mass spectroscopy detector.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDariush Omidfar

Simin Baspar Teyf Gostar Company

Dariush.omidfar@gmail.com+98 41 3384 2724

Outcome results

None listed

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