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In-vivo Bioequivalence Study of Pantoprazole 40 mg Delayed Release Tablets of The Test Drug (Kosar Pharma, Iran)

In-vivo Bioequivalence Study of Pantoprazole 40 mg Delayed Release Tablets of The Test Drug (Kosar Pharma, Iran) Compared with The Reference Drug (Pantazol® 40 mg, Takeda, Germany) In Iranian Healthy Volunteers

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
IRCT
Registry ID
IRCT20200105046010N144
Enrollment
24
Registered
2025-06-18
Start date
2025-06-22
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

This study is performed on healthy volunteers..

Interventions

Intervention 1: Intervention group: Single-dose of Pantoprazole 40 mg Delayed Release Tablets of The Test Drug (Kosar Pharma, Iran) , in the first period. Cross-over design with one week washing peri

Sponsors

Kosar Pharma
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 55 Years

Inclusion criteria

Inclusion criteria: General health (liver, heart, kidney) of volunteers Body mass index range (18-30) Informed consent form Age between18-55

Exclusion criteria

Exclusion criteria: Smoking Pregnancy Having a hypersensitivity to the drug Having a Alcohol & Drug addiction Blood donation within the last 6 months

Design outcomes

Primary

MeasureTime frame
The concentration of the drug in blood. Timepoint: 0? ?/5? 1? 1/5? 2? 2/5? 3? 3/5? ?? ?/5? 5? 5/5? 6? 8? 1?? 12 h after drug administration. Method of measurement: Liquid Chromatography with Mass-Mass Detector.

Secondary

MeasureTime frame
Time to reach maximum blood concentration. Timepoint: After intervention. Method of measurement: The time to reach the maximum drug concentration in blood is recorded.;Extent of absorption. Timepoint: After intervention. Method of measurement: Calculation of area under curve of concentration -time.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactJavad Shokri

Tabriz University of Medical Sciences

shokri.j@gmail.com+98 41 3661 4125

Outcome results

None listed

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