Investigating the in vivo bioequivalence of Esomeprazole 40 mg capsule

In vivo fasted-state bioequivalence study of Esomeprazole 40 mg Capsules manufactured by Ronak Pharmaceutical Co. compared to innovator product

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20210519051345N68

Enrollment

Registered

2024-11-12

Start date

2024-11-20

Completion date

Unknown

Last updated

2025-01-08

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

Conditions

In the present study, the products will be administered to healthy volunteers.

Interventions

Intervention 1: Intervention group: Intervention group will receive a single oral dose of test product (Esomeprazole capsule manufactured by Ronak Co.) in fasted state. Blood samples will be collected

Eligibility

Sex/Gender

All

Age

18 Years to 55 Years

Inclusion criteria

Inclusion criteria: General Health (in terms of Liver, Heart and Kidney) Age between 18-55 years

Exclusion criteria

Exclusion criteria: Smoking History of cardiovascular disease, liver and kidney disease Pregnancy Alcohol and drug addiction History of drug allergy

Design outcomes

Primary

Measure	Time frame
Plasma concentration of drug. Timepoint: 0.5-12 hours in predetermined time intervals after drug administration. Method of measurement: HPLC (High performance liquid chromatography).	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactParvin Zakeri-Milani

Tabriz University of Medical Sciences

pzakeri@tbzmed.ac.ir+98 41 3334 8801

Outcome results

None listed

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