Tamsulosin Hydrochloride 0.4 mg Capsules Under Fed Conditions

• ClinicalTrials.gov Identifier: NCT01149733
• Recruitment Status: Completed
• First Posted: June 23, 2010
• Results First Posted: September 13, 2010
• Last Update Posted: September 13, 2010
• Sponsor: Teva Pharmaceuticals USA
• Information provided by: Teva Pharmaceuticals USA

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Healthy	Drug: Tamsulosin	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 32 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Official Title: A Single-Dose, Comparative Bioavailability Study of Two Formulations of Tamsulosin Hydrochloride 0.4 mg Capsules Under Fed Conditions
• Study Start Date: November 2004
• Actual Primary Completion Date: November 2004
• Actual Study Completion Date: November 2004

Arms and Interventions

Arm	Intervention/treatment
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 Capsule; Other Name: Flomax®

Outcome Measures

Primary Outcome Measures :

1. Cmax (Maximum Observed Concentration of Drug Substance in Plasma) [ Time Frame: Blood samples drawn over 60 hour period ]
   Bioequivalence based on Cmax
2. 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 period ]
   Bioequivalence based on AUC0-t
3. AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity) [ Time Frame: Blood samples drawn over 60 hour period ]
   Bioequivalence based on AUC0-inf

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes 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

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

• Responsible Party: Teva Pharmaceuticals USA
• ClinicalTrials.gov Identifier: NCT01149733
• Other Study ID Numbers: 2004-823
• First Posted: June 23, 2010
• Results First Posted: September 13, 2010
• Last Update Posted: September 13, 2010
• Last Verified: August 2010

Additional relevant MeSH terms:

Malnutrition; Nutrition Disorders; Tamsulosin; Adrenergic alpha-1 Receptor Antagonists; Adrenergic alpha-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Physiological Effects of Drugs; Urological Agents