In-Vivo Bioequivalence study of Pantoprazole 40 mg Delayed Release Tablets of The Test Drug (Pantoprazole 40 mg EC., Abidi Pharma, Iran)

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

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20200105046010N134

Enrollment

Registered

2025-02-02

Start date

2024-11-20

Completion date

Unknown

Last updated

2025-02-03

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

Conditions

In this study the bioequivalence of test and brand of Pantoprazole® will be evaluated.

Interventions

Intervention 1: Intervention group 1: Single-dose of the test drug Pantoprazole 40 mg EC. Tablet (Pantoprazole_Abidi 40 mg Tab., Abidi Pharma, Iran) in the first period.after washout period, the volun

Eligibility

Sex/Gender

All

Age

18 Years to 55 Years

Inclusion criteria

Inclusion criteria: General health(liver, heart, kidney) Body mass index(18-28) Informed consent Age(18-55)

Exclusion criteria

Exclusion criteria: Smoking Pregnancy Alcohol & Drug addiction Hypersensitivity to the drug

Design outcomes

Primary

Measure	Time frame
Plasma concentration of the drug. Timepoint: 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 10 and 12 hours after drug administration. Method of measurement: HPLC-MS/MS.	—

Secondary

Measure	Time frame
Time to reach maximum plasma concentration. Timepoint: After intervention. Method of measurement: Time to reach the maximum drug concentration in plasma 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 ContactZahra Nemati

Radin Shimi Co.

shokri.j@gmail.com+98 41 3334 8489

Outcome results

None listed

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