Study of absorption and elimination rate of Pantoprazole 40 mg tablets in comparison with standard tablets of Pantoprazole (Pantonix®).

Randomized, single-dose, crossover comparative bioequivalence study of the Pantoprazole 40 mg tablet produced by Modava pharmaceutical Co versus Pantonix® (Wyeth company) in 24 healthy males under fasting conditions

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20200407046981N14

Enrollment

Registered

2021-09-05

Start date

2021-10-23

Completion date

Unknown

Last updated

2021-11-01

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

Conditions

Bioequivalence study.

Interventions

Intervention 1: Intervention group 1: In this group, volunteers are given a single oral dose of pantoprazole 40 mg tablet produced by Modava Co. (Domestic). After the washout period, the volunteers ar

Eligibility

Sex/Gender

Female

Age

18 Years to 55 Years

Inclusion criteria

Inclusion criteria: The weight limit for each volunteer is between 60 and 100 kg. They must be healthy in terms of liver, kidney, respiratory system, mental and other general health characteristics that will be assessed.

Exclusion criteria

Exclusion criteria: Known hypersensitivity or idiosyncratic reaction to Pantoprazole or any ingredients. Subjects with BP = 90/60 mm/Hg or BP = 140/90 mm/Hg. Regular smoker who smokes more than ten cigarettes daily.

Design outcomes

Primary

Measure	Time frame
Peak Plasma Concentration (Cmax). Timepoint: At 0 (before dosing), 1? 2? 2.5? 3? 3.5? 4? 4.5? 5? 6? 8? 10? 12? 24 and 36 hour after dosing. Method of measurement: High-performance liquid chromatography—mass spectrometry (HPLC-MS).	—

Secondary

Measure	Time frame
AUC (Area Under the Concentration-Time Curve). Timepoint: At 0 (before dosing), 1? 2? 2.5? 3? 3.5? 4? 4.5? 5? 6? 8? 10? 12? 24 and 36 hour after dosing. Method of measurement: Using non-compartmental model of Win-Nonlin Professional software version 3.2.A (Pharsight Corporation, USA) or SPSS.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHamed Hamishehkar

Tabriz University of Medical Sciences

Hamishehkar.hamed@gmail.com+98 41 3336 7914

Outcome results

None listed

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