Tamsulosin Hydrochloride 0.4 mg Capsules Under Fed Conditions

NCT01149733 | Completed Phase 1 Results

• 1 other identifier: 2004-823
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• Cmax (Maximum Observed Concentration of Drug Substance in Plasma)

  Bioequivalence based on Cmax

  Blood samples drawn over 60 hour period

• AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)

  Bioequivalence based on AUC0-t

  Blood samples drawn over 60 hour period

• AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)

  Bioequivalence based on AUC0-inf

  Blood samples drawn over 60 hour period

Study Arms (2)

Tamsulosin

EXPERIMENTAL

0.4 mg Capsule

Drug: Tamsulosin

Flomax®

ACTIVE COMPARATOR

0.4 mg Capsule

Drug: Tamsulosin

Interventions

Tamsulosin DRUG

Test 0.4 mg Capsule

Tamsulosin

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Teva Pharmaceuticals USA: lead

Study Sites (1)

Pharma Medica Research Inc.

Toronto, Ontario, M1R 5A3, Canada

Location

MeSH Terms

Interventions

Tamsulosin

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds

Results Point of Contact

• Title: Associate Director, Biopharmaceutics
• Organization: Teva Pharmaceuticals USA

clinicaltrialqueries@tevausa.com

866-384-5525

Study Officials

• Xueyu (Eric) Chen, M.D., Ph. D., FRCP (C)

  Pharma Medica Research, Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 22, 2010
• First Posted: June 23, 2010
• Study Start: November 1, 2004
• Primary Completion: November 1, 2004
• Study Completion: November 1, 2004
• Last Updated: August 20, 2024
• Results First Posted: September 13, 2010

Record last verified: 2024-08

Locations

CA (1)