Bioequivalence study of methylphenidate hydrochloride 10 mg tablet

Bioequivalence study of methylphenidate hydrochloride 10 mg tablet of Jalinous pharmaceutical company compared to methylphenidate hydrochloride 10 mg sample of Novartis company in Switzerland on healthy volunteers

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20230222057495N15

Enrollment

Registered

2024-04-13

Start date

2024-04-20

Completion date

Unknown

Last updated

2024-05-27

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 methylphenidate hydrochloride tablets of 10 mg from Iran Jalinous Pharmaceutical Company on 24 fasting healthy volunteers. 5 ml of blo

Eligibility

Sex/Gender

All

Age

18 Years to 55 Years

Inclusion criteria

Inclusion criteria: Healthy volunteer between 18 and 55 years old. 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
The maximum plasma concentration of methylphenidate hydrochloride. Timepoint: before taking the drug and: 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 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