Bioequivalence study of aripiprazole 5 mg tablet

Bioequivalence study of aripiprazole 5 mg tablet from Kimidaro Pharmaceutical Company compared to aripiprazole 5 mg sample from Otsuka Pharmaceutical Netherlands B.V. United Kingdom on healthy volunteers

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20230222057495N6

Enrollment

Registered

2023-06-11

Start date

2023-05-22

Completion date

Unknown

Last updated

2023-06-26

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 consumption of a 5 mg aripiprazole tablet manufactured by Kimidarou Pharmaceutical Company of Iran on 24 healthy fasting volunteers. 5 ml of blo

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Healthy volunteers aged between 18 and 65 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 Aripiprazole. Timepoint: Before taking the drug and: 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 24, 48 and 72 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