Bioequivalence study of dapoxetine 60 mg tablet

Bioequivalence study of dapoxetine 60 mg tablet of Sami Saz pharmaceutical company compared to dapoxetine 60 mg sample of Menarini company in England on healthy volunteers

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20230222057495N8

Enrollment

Registered

2023-08-07

Start date

2023-08-11

Completion date

Unknown

Last updated

2023-08-21

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

Conditions

None listed

Interventions

Intervention 1: Intervention group 1: includes the oral intake of Dapoxetine 60 mg tablets of Sami Saz Pharmaceutical Company of Iran on 24 healthy fasting volunteers. 5 ml of blood will be taken from

Eligibility

Sex/Gender

All

Age

18 Years to 55 Years

Inclusion criteria

Inclusion criteria: Healthy volunteers aged between 18 and 55 years Body mass index less than 30 kg per square meter All candidates must be non-smokers

Exclusion criteria

Exclusion criteria: Blood pressure less than 90 over 60 mm Hg or more than 140 over 90 mm Hg Consumption of any drugs, alcohol or tobacco products within 2 weeks before receiving the drug

Design outcomes

Primary

Measure	Time frame
The maximum plasma concentration of dapoxetine. Timepoint: before starting to take the drug and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 24 and 48 hours after taking the drug. Method of measurement: Liquid chromatography-mass spectrometry.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMonireh Jalalipour

Nik Azma Pars Alborz laboratory

info@naplab.ir+98 26 3731 8748

Outcome results