Clinical study to compare the in vivo parameters of 2 Tamsulosin 0.4 mg ER Capsule formulations

Not Applicable

Conditions: Bioequivalence investigation of the generic Dorsa Pharmaceutical Co. Tamsulosin 0.4 mg ER capsule with Omnic astellas brand capsule..

Registration Number: IRCT20180620040164N26

Lead Sponsor: Dorsa Pharmaceutical Co.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: Male

Target Recruitment: 24

Inclusion Criteria

Healthy Subjects should be between 20-45 years old.
Subjects with BMI in the range of 15% of the normal range (kg per square meter) 18.5-30.
Subjects with no significant diseases or clinically significant abnormal findings during screening, medical history, clinical examination and laboratory evaluations.
Subjects must have normal vital signs.
Subjects agree to all clinical study requirements based on clinical study guidelines that have been approved by accepting the informed consent form.

Exclusion Criteria

History of known allergies to test products.
Subject with a history of neoplastic disease (cancer), stroke, chronic seizures or major neurological disorder, clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases.
Smokers who smoke more than 10 cigarettes a day and have trouble not smoking during each clinical study period.
Subjects who has used any drug including prescription or Over The-Counter (OTC) drugs within 14 days prior to the start of the study and might need drug intake during study period.
People who have a history of alcoholism or alcohol consumption in the past 2 years.
Heavy drinker of caffeine, grapefruit juice or caffeinated drinks.
who are on special diet (such as vegetarians).
Who do exertional physical activity.
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: 14 blood samples up to 48 hours and sample analysis during 3 months 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: 14 blood samples up to 48 hours and sample analysis during 3 months after intervention. Method of measurement: Using non-compartmental model of Win-Nonlin Professional software version 3.2.A (Pharsight Corporation, USA).