bioequivalence study of Omeprazole 50 mg tablet in 24 healthy male under fasting conditions

Not Applicable

Conditions: Gastric ulcer.
Gastric ulcer

Registration Number: IRCT20180620040164N58

Lead Sponsor: ACtover Pharmaceutical Co.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Male

Target Recruitment: 24

Inclusion Criteria

Healthy subjects (male) should be between 20-45 years old.
subjects how have body mass index (BMI) Within 15% of normal range between 18.5-30 (Kg/m2)
Subjects with normal vital signs.
Subjects who agree with patient consent form.

Exclusion Criteria

Subjects with known allergy to the products tested.
Subjects must not have a historical specific diseases or abnormal values in labratory tests and general clinical examination.
Chronic or acute diseases of the digestive system, such as diseases related to the esophagus, gastritis, peptic ulcer, intestinal inflammation, bleeding in the digestive tract, or digestive system surgery during the last three years.
Having problems with vascular system, endocrine system, nervous system, digestive system, respiratory system, blood system, immune system, mental and metabolic system.
Performing surgery within 4 weeks before drug administration or at the time of clinical study.
Smoking more than 10 cigarettes per day, losing more than 500 ml of blood in less than 7 days.
A history of difficulty with donating blood or donation of more than 500 ml blood within 7 days prior to the start of the study.

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Peak Plasma Concentration (Cmax). Timepoint: 17 blood samples will be withdrawn pre-dose and at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 3, 4, 6, 8, 10, 12 and 24 hours after intervention. Method of measurement: Using non-compartmental model of Win-Nonlin Professional software version 3.2.A (Pharsight Corporation, USA).

Secondary Outcome Measures

Name	Time	Method
AUC (Area Under the Concentration-Time Curve). Timepoint: 17 blood samples will be withdrawn pre-dose and at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 3, 4, 6, 8, 10, 12 and 24 hours after intervention. Method of measurement: Using non-compartmental model of Win-Nonlin Professional software version 3.2.A (Pharsight Corporation, USA).