Bioequivalence study of bisoprolol fumarate hydrochlorothiazide tablet 10/25 mg

Bioequivalence study of bisoprolol fumarate hydrochlorothiazide 10.25 mg tablets of Sami Saz pharmaceutical company compared to samples of bisoprolol fumarate 10 mg from Merck Germany and hydrochlorthiazide 25 mg from Juvise France on healthy volunteers

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20230222057495N9

Enrollment

Registered

2023-08-19

Start date

2023-08-11

Completion date

Unknown

Last updated

2023-10-16

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 bisoprolol fumarate hydrochlorothiazide 10.25 mg tablets of Sami Saz Pharmaceutical Company of Iran on 24 fasting healthy volunteers.

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 drugs, alcohol or tobacco products within 2 weeks before receiving the drug

Design outcomes

Primary

Measure	Time frame
Maximum plasma concentrations of bisoprolol fumarate and hydrochlorothiazide. Timepoint: Before taking the medicine and: 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 7, 9, 10, 24, 34 and 48 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