Bioequivalence study of domperidone suspension 1 mg/ml

Bioequivalence study of domperidone suspension 1 mg/ml of Sina pishgam Darou Novin pharmaceutical company compared to domperidone 1 mg/ml sample of JANSSEN CILAG company of Belgium on healthy volunteers

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20230222057495N7

Enrollment

Registered

2023-07-03

Start date

2023-07-01

Completion date

Unknown

Last updated

2023-07-25

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 oral administration of Domperidone suspension 1 mg/ml manufactured by Sina pishgam Darou Novin Pharmaceutical Company of Iran on 24 healthy fasting volun

Eligibility

Sex/Gender

All

Age

18 Years to 50 Years

Inclusion criteria

Inclusion criteria: Healthy volunteers aged between 18 and 50 years All candidates must be non-smokers Body mass index less than 30 kg per square meter

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
Maximum plasma concentration of domperidone. Timepoint: Before taking the drug and: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours after taking the drug. Method of measurement: Liquid Chromatography - Fluorescence.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMonireh Jalalipour

Nik Azma Pars Alborz laboratory

info@naplab.ir+98 26 3731 8748

Outcome results