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Tamsulosin Hydrochloride 0.4 mg Capsules Under Fasting Conditions

This study has been completed.
Sponsor:
Information provided by:
Teva Pharmaceuticals USA
ClinicalTrials.gov Identifier:
NCT01149746
First received: June 22, 2010
Last updated: NA
Last verified: June 2010
History: No changes posted
  Purpose

The objective of this study is to evaluate the comparative bioavailability between Tamsulosin Hydrochloride 0.4 mg Capsules (Teva Pharmaceuticals USA) and Flomax® 0.4 mg Capsules (Boehringer Ingelheim Pharmaceuticals, Inc. USA), after a single-dose in healthy subjects under fasting conditions.


Condition Intervention Phase
Healthy
 Drug: Tamsulosin
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: A Single-Dose, Comparative Bioavailability Study of Two Formulations of Tamsulosin Hydrochloride 0.4 mg Capsules Under Fasting Conditions

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Teva Pharmaceuticals USA:

Primary Outcome Measures:
  • Cmax (maximum observed concentration of drug substance in plasma) [ Time Frame: Blood samples drawn over 60 hour time period ] [ Designated as safety issue: No ]
    Bioequivalence based on Cmax

  • AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration) [ Time Frame: Blood samples drawn over 60 hour time period ] [ Designated as safety issue: No ]
    Bioequivalence based on AUC0-t

  • AUC0-inf (area under the concentration-time curve from time zero to infinity) [ Time Frame: Blood samples drawn over 60 hour time period ] [ Designated as safety issue: No ]
    Bioequivalence based on AUC0-inf


Enrollment: 32
Study Start Date: December 2004
Study Completion Date: December 2004
Primary Completion Date: December 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tamsulosin
0.4 mg Capsule
 Drug: Tamsulosin
Test 0.4 mg Capsule
Active Comparator: Flomax®
0.4 mg Capsule
 Drug: Tamsulosin
Reference Listed 0.4 mg Capsule
Other Name: Flomax®

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01149746

Locations
Canada, Ontario
Pharma Medica Research Inc.
Toronto, Ontario, Canada, M1R 5A3
Sponsors and Collaborators
Teva Pharmaceuticals USA
Investigators
Principal Investigator: Xueyu (Eric) Chen, M.D., Ph. D., FRCP (C) Pharma Medica Research Inc.
  More Information

No publications provided

Responsible Party: Associate Director, Biopharmaceutics, Teva Pharmaceuticals USA
ClinicalTrials.gov Identifier: NCT01149746     History of Changes
Other Study ID Numbers: 2004-824
Study First Received: June 22, 2010
Last Updated: June 22, 2010
Health Authority: Canada: Ethics Review Committee

Additional relevant MeSH terms:
Tamsulosin
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
 Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 22, 2013