Bioequivalence study of Pantoprazole 40mg

Bioequivalence study of Pantoprazole 40 mg tablet manufactured by Sanamed company versus the originator brand in fed and fast condition in healthy volunteers

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20200623047902N7

Enrollment

Registered

2021-09-15

Start date

2024-10-22

Completion date

Unknown

Last updated

2024-07-22

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

Conditions

Healthy volunteers.

Interventions

Intervention 1: Intervention group: single dose, one oral tablet 40 mg (Protonix) manufactured by Pfizer, as reference product. Intervention 2: Intervention group: Single dose, one oral tablet of Pant

Eligibility

Sex/Gender

All

Age

18 Years to 55 Years

Inclusion criteria

Inclusion criteria: General Health (liver, heart, and kidney) Body Mass Index (18-28) Informed consent Age (18-55 years old)

Exclusion criteria

Exclusion criteria: Smoking History of cardiovascular disease History of liver and kidney disease Alcoholism and Narcoticism History of allergy to pantoprazole

Design outcomes

Primary

Measure	Time frame
Drug plasma concentration. Timepoint: 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 10, 12 h after drug administration. Method of measurement: HPLC -MASS-MASS.	—

Secondary

Measure	Time frame
Pharmacokinetic parameters. Timepoint: After intervention. Method of measurement: Theoretical and pahrmacokinetic equations.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactElham Ghasemian

Islamic Azad University

ghasemian_elham@yahoo.com+98 23 3522 5046

Outcome results

None listed

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