Bioequivalence study of ranolazine 500 mg extended-release tablets

Bioequivalence study of Ranolazine 500 mg extended release tablets from Teb Mofid Nikan Pharmaceutical Company compared to Ranolazine 500 mg extended release tablets from Menarini Company, Luxembourg, on healthy volunteers.

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20230222057495N29

Enrollment

Registered

2025-10-01

Start date

2025-09-27

Completion date

Unknown

Last updated

2025-10-13

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 ranolazine 500 mg extended release tablets from Teb Mofid Nikan Pharmaceutical Company, Iran, to 24 healthy fasting volunteers. 5

Eligibility

Sex/Gender

All

Age

18 Years to 55 Years

Inclusion criteria

Inclusion criteria: Healthy volunteers between the ages of 18 and 55. Body mass index less than 30 kg/m2. All volunteers 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 ranolazine. Timepoint: Before starting the drug and: 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 10, 24 and 48 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 3610 6037

Outcome results