Bioequivalence Study of Dapoxetine 30 mg Tablet

Bioequivalence Study of Dapoxetine 30 mg Tablets Manufactured by Pursina Pharmaceutical Company by Innovative Company

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20231108059993N11

Enrollment

Registered

2026-01-19

Start date

2025-12-22

Completion date

Unknown

Last updated

2026-02-02

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

Conditions

Healthy volunteers were enrolled in the study..

Interventions

Intervention group: The first intervention group, which has been randomly and single-blindly selected, will take the Iranian Dapoxetine 30 mg tablets, and the second group will take a brand drug . Af

Eligibility

Sex/Gender

Male

Age

18 Years to 55 Years

Inclusion criteria

Inclusion criteria: Good general health (liver, heart, and kidneys). Body mass index (18-28). Informed consent Ages range (18-55years).

Exclusion criteria

Exclusion criteria: Addiction to alcohol, drugs and cigarettes Allergy to Dapoxetine Chronic disease treatment history

Design outcomes

Primary

Measure	Time frame
Drug Plasma Concentration. Timepoint: 0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 46, 72 hour. Method of measurement: Liquid chromatography with dual mass spectrometer (LC/M?S/MS).	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSaeed Ghanbarzadeh

Tabriz University of Medical Sciences

s_ghanbarzadeh@yahoo.com0413832649

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 7, 2026