Bioequivalence study of Ondansetron 4 mg film-coated tablet in 24 healthy male under fasting conditions

Randomized, single-dose, crossover comparative bioequivalence study of Ondansetron 4 mg film-coated tablets of Aburaihan Pharmaceutical Co. and Zofran 4 mg film-coated tablet of Novartis Co. in 24 healthy male under fasting conditions

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20180620040164N2

Enrollment

Registered

2019-05-12

Start date

2018-12-22

Completion date

Unknown

Last updated

2019-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bioequivalence investigation of the generic (Aburaihan co.) Ondansetron 4 mg tablet with brand (Novartis co.) zofran 4 mg tablet..

Interventions

Intervention 1: Intervention group (Test): Ondansetron 4 mg film-coated tablet, produced by Aburaihan pharmaceutical co. is the test product. In each period, 12 of 24 subjects will be given single ora

Eligibility

Sex/Gender

Male

Age

18 Years to 45 Years

Inclusion criteria

Inclusion criteria: Healthy subjects with BMI 18.5-30 kg/m2 Not having a history of any significant disease. Not having any abnormal finding in laboratory examination or during physical examination. Subjects who agree with patient consent form.

Exclusion criteria

Exclusion criteria: Known hypersensitivity or idiosyncratic reaction to Ondansetron or any ingredients. Subjects with BP = 9060 mm/Hg or BP = 140/90 mm/Hg Any evidence of impairment of renal, hepatic, cardiac, lung or gastrointestinal function or a history of TB, epilepsy, asthma (during past 5 years), DM, psychosis or glaucoma. Regular smoker who smokes more than ten cigarettes daily. Taking any medicine during two week before dosing

Design outcomes

Primary

Measure	Time frame
Peak Plasma Concentration (Cmax). Timepoint: During 2 months after intervention. Method of measurement: using non-compartmental model of Win-Nonlin Professional software version 3.2.A (Pharsight Corporation, USA).	—

Secondary

Measure	Time frame
AUC (Area Under the Concentration-Time Curve). Timepoint: During 2 months after intervention. Method of measurement: Using non-compartmental model of Win-Nonlin Professional software version 3.2.A (Pharsight Corporation, USA).	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAli Aghaei

Tavan Institute

info@tavaninstitute.ir+98 21 6600 4027

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026