Comparative in vivo evaluation of 2 ?Lansoprazole 30 mg Capsule formulations.

Bioequivalence study of ?Lansoprazole 30 mg Capsule of Dorsa Pharmaceutical Co. and Agopton of Takeda as reference in 24 healthy male under fasting.

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20180620040164N66

Enrollment

Registered

2024-06-22

Start date

2024-08-06

Completion date

Unknown

Last updated

2024-06-24

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

Conditions

Eosinophilic esophagitis. Eosinophilic esophagitis

Interventions

Intervention 1: Intervention group 1: Lansoprazole 30 mg Capsule , produced by Dorsa Pharmaceutical Co. is the test product. In each period, 12 of 24 subjects will be given single oral dose of this pr

Eligibility

Sex/Gender

Male

Age

18 Years to 45 Years

Inclusion criteria

Inclusion criteria: Healthy subjects (male) between 18 – 45 years of age and Body Mass Index (BMI) between 18.5 and 30 (inclusive), calculated as kg/m2. Subjects with no significant diseases or clinically significant abnormal findings during screening, medical history, clinical examination and laboratory evaluations. Subjects with normal vital signs. Subjects who agree with patient consent form.

Exclusion criteria

Exclusion criteria: History of known sensitivity to the tested product History of specific disease or unusual values ??in laboratory tests and general clinical examination Hypertension (blood pressure in a standing position and after at least 5 minutes of rest, systole greater than or equal to 140 mmHg and diastole greater than or equal to 90 mmHg) Smoking more than 10 cigarettes a day Loss of more than 500 ml of blood in less than 7 days.

Design outcomes

Primary

Measure	Time frame
Peak Plasma Concentration (Cmax). Timepoint: 14 blood samples will be withdrawn pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8 and 12 hours after intervention. Method of measurement: Using non-compartmental model of Win-Nonlin Professional software version 3.2.A (Pharsight Corporation, USA).	—

Secondary

Measure	Time frame
AUC (Area Under the Concentration-Time Curve). Timepoint: 14 blood samples will be withdrawn pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8 and 12 hours after intervention. Method of measurement: Using non-compartmental model of Win-Nonlin Professional software version 3.2.A (Pharsight Corporation, USA).	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactBehzad Montaha Sangari

Noor Research & Development Institute

info@tavaninstitute.ir+98 21 6600 4027

Outcome results

None listed

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