Bioequivalence study of tablets of Esomeprazole 40 mg

Bioequivalence study of Tablet Esomeprazole 40 mg of Koushan Pharmed pharmaceutical company compared to the sample of Esomeprazole 40 mg of AstraZeneca Company in Sweden on healthy volunteers

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20230222057495N17

Enrollment

Registered

2024-06-10

Start date

2024-06-21

Completion date

Unknown

Last updated

2024-06-24

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 Esomeprazole 40 mg tablets by Iran's Koushan Pharmed pharmaceutical company on 24 fasting healthy volunteers. 5 ml of blood at time in

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 on 60 mm Hg or more than 140 on 90 mm Hg. Consumption of any drug, alcohol or tobacco within 2 weeks before receiving the drug.

Design outcomes

Primary

Measure	Time frame
Maximum plasma concentration of Esomeprazole. Timepoint: Before starting to take the drug and: 20 and 40 minutes, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 3, 3.5, 4, 5, 6, 8 and 10 hours after taking the medicine. 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