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Bioequivalence study of Lansoprazole 30 mg capsule

Bioequivalence study of Lansoprazole 30 mg manufactured by Actover Co. versus originator brand in healthy volunteers in fasting condition

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
IRCT
Registry ID
IRCT20200623047902N40
Enrollment
24
Registered
2024-03-17
Start date
2024-04-20
Completion date
Unknown
Last updated
2024-05-27

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, one oral Prevacid capsule 30mg manufactured by Takeda as a reference product. after the washout period, the volunteers received lansacto capsule 30mg

Sponsors

Actover Co
Lead Sponsor

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 lansoprazole

Design outcomes

Primary

MeasureTime frame
Drug concentration in plasma. Timepoint: 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12 h after drug administration. Method of measurement: Liquid chromatography-MASS-MASS (LC- Mas/Mas).

Secondary

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

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