Tamsulosin Hydrochloride 0.4 mg Capsules Under Fed Conditions
Condition: Healthy
MeSH terms: Malnutrition
Intervention: Tamsulosin; Tamsulosin
Intervention description: Test 0.4 mg Capsule; Reference Listed 0.4 Capsule
Intervention MeSH terms: Tamsulosin
Phase: Phase 1
Study type: Interventional
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The objective of this study is to evaluate the comparative bioavailability between tamsulosin
      hydrochloride 0.4 mg capsules (Manufactured by Teva Pharmaceutical Industries Ltd.;
      distributed by Teva Pharmaceuticals USA) and Flomax® (tamsulosin hydrochloride)0.4 mg
      capsules (Manufactured by Yamanouchi Pharmaceutical Co., Japan; distributed by Boehringer
      Ingelheim Pharmaceutical Inc. USA), after a single-dose in healthy subjects under fed
      conditions.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy, non-smoking male subjects, 18 years of age or older.

          -  BMI greater than or equal to 19 and less than or equal to 30.

          -  Negative for:

               -  HIV.

               -  Hepatitis B surface antigen and Hepatitis C antibody.

               -  Using drugs of abuse test (marijuana, amphetamines, barbiturates, cocaine,
                  opiates, benzodiazepines and methadone).

               -  Urine cotinine test

          -  No significant diseases or clinically significant findings in a physical examination.

          -  No clinically significant abnormal laboratory values.

          -  No clinically significant findings in vital signs measurements and a 12-lead
             electrocardiogram (ECG).

          -  Systolic blood pressure between 100-140 mmHg and diastolic blood pressure between
             60-90 mmgHg.

          -  Be informed of the nature of the study and given written consent prior to receiving
             any study procedure.

        Exclusion Criteria:

          -  Known history or presence of any clinically significant medical condition, illness or
             surgery within 4 weeks prior to drug administration.

          -  Known or suspected carcinoma.

          -  Known history or presence of:

               -  Hypersensitivity or idiosyncratic reaction to tamsulosin and/or any other drug
                  substances with similar activity.

               -  Alcoholism within the last 12 months.

               -  Drug dependence and/or substance abuse.

               -  Use of tobacco or nicotine-containing products within the last 6 months.

          -  Use of any prescription medication within 14 days prior to Period 1 dosing. Use of any
             over the counter (OTC) medication within 7 days prior to Period 1 dosing.

          -  Use of any drugs known to induce or inhibit hepatic drug metabolism within 30 days
             prior to Period 1 dosing.

          -  On a special diet within 4 weeks prior to drug administration (e.g. liquid, protein,
             raw food diet).

          -  Participated in another clinical trial or received and investigational product within
             30 days prior to drug administration.

          -  Donated up to 250 mL of blood within the previous 30 days OR Donated from 251 to 500
             mL of blood in the previous 45 days OR Donated more than 500 mL of blood in the
             previous 56 days (based on the Canadian Blood Services guideline for blood donation.

          -  Difficulty fasting or consuming the standard meals.

          -  Do not tolerate venipuncture.

          -  Unable to read or sign the ICF.