Bioequivalence study of Dapoxetine 30mg tablet of Alborz Darou Pharm Co., IRAN

A randomized, open label, two treatments, single dose, crossover, bioequivalence study of Dapoxetine 30mg tablet of Alborz Darou Pharm Co., IRAN in comparison of Priligy 30mg tablet of Menarini in 24 healthy adult subjects under fasting condition

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20190706044111N18

Enrollment

Registered

2020-05-21

Start date

2020-06-21

Completion date

Unknown

Last updated

2020-06-15

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

Conditions

Premature ejaculation. Premature ejaculation

Interventions

Intervention 1: Intervention group: Single dose of two Dapoxetine 30mg tablets of Alborz Darou Pharm Co., IRAN. Intervention 2: Control group: Single dose of two Priligy 30mg tablets of Menarini.

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: Subject had undergone surgery of the gastro-intestinal tract Subject had donated a unit of blood or participated in another clinical trial, within the last two months before the first treatment. Subject had a history of drug or alcohol abuse. Subject who smokes more than 10 cigarettes per day. Subject had used any prescription medication within 14 days, or any non-prescription medication within 7 days, before the first treatment.

Design outcomes

Primary

Measure	Time frame
Plasma concentration of dapoxetine. Timepoint: At 0 (before dosing), 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 10.0, 24.0 & 48.0 hr. after drug administration. 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