A Study To Compare Giving AVODART And FLOMAX Together Or In A Combination Capsule In The Fed And Fasted State

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00537654
First received: September 28, 2007
Last updated: October 13, 2010
Last verified: October 2010
  Purpose

AVODART and tamsulosin are to treat benign prostatic hyperplasia. Studies show that when given together, there is more improvement in symptoms than either drug alone. In this study, we are looking to see if the drugs work the same in the body when giving AVODART and FLOMAX at the same time compared to when they are given in a combination capsule in a fed and fasted state. This study will be in healthy adult males.


Condition Intervention Phase
Benign Prostatic Hyperplasia
Drug: GI198745
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: See Detailed Description

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • PK at 0,1,2,3,4,5,6,7,8,10,12,16,24,36,48,72 [ Time Frame: PK at 0,1,2,3,4,5,6,7,8,10,12,16,24,36,48,72 ]

Secondary Outcome Measures:
  • Safety and tolerability of all treatments as assessed by blood pressure and pulse rate measurements, adverse events and clinical laboratory safety tests.
  • Blood levels and derived pharmacokinetic parameters for for both tamsulosin and dutasteride,

Enrollment: 81
Study Start Date: October 2007
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: GI198745
    Other Name: GI198745
Detailed Description:

An Open-Label, Randomized, Single Dose Three-Period Partial Crossover Study to Determine the Bioequivalence and Food Effect of a Combination Capsule Formulation of Dutasteride and Tamsulosin Hydrochloride (0.5mg/0.4mg) Compared to Concomitant Dosing of AVODART 0.5mg and FLOMAX 0.4mg Commercial Capsules in Healthy Male Subjects

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  • Healthy subjects defined as individuals who are free from clinically significant illness or disease as determined by the investigator based on their medical history, physical examination, laboratory studies, ECGs, and other tests.
  • Males who are 18 - 45 years of age, inclusive.
  • Weight range 55 - 95 kg (inclusive) and body mass index 19 - 30 kg/m2 (inclusive).
  • Willing and able to give written informed consent, willing to participate for the full duration of the study, and able to understand and follow instructions related to study procedures

Exclusion criteria:

  • Slow metabolizer for CYP2D6 as determined by screening PGx analysis.
  • History of postural hypotension, dizziness, poor hydration, vertigo, vaso-vagal reactions or any other signs and symptoms of orthostasis, which in the opinion of the investigator could be exacerbated by tamsulosin and result in putting the subject at risk of injury.
  • Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements within 7 days (or 14 days if the drug is a potential enzyme inducer, such as St. John's Wort) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the investigator and sponsor the medication will not interfere with the study procedures or compromise subject safety.
  • Chronic hepatitis B and C, as evidence by positive Hepatitis B surface antigen (HBsAg) or Hepatitis C antibody.
  • Positive HIV test at screening.
  • History of sensitivity to heparin or heparin-induced thrombocytopenia.
  • History of regular alcohol consumption exceeding 14 drinks/week for men (1 drink = 5 ounces of wine or 12 ounces of beer or 1.5 ounces of hard liquor) within 6 months of screening. Subjects must be able and willing to abstain from beverages and foods containing alcohol 24 hours prior to and during the dosing day.
  • A positive urine drug or alcohol (Breath test or urine) screen result at screening or check-in..
  • The subject has received an investigational drug or participated in any other research trial within 30 days or 5 half-lives, or twice the duration of the biological effect of any drug (whichever is longer) prior to the first dose of current study medication or anytime during the study period.
  • Where participation in study would result in donation of blood in excess of 500 mL within a 56 day period.
  • History or presence of allergy, intolerance, or contraindication to tamsulosin HCl or AVODART or drugs of this class, or a history of drug or other allergy (including true sulfonamide allergy) that, in the opinion of the physician responsible, contraindicates their participation.
  • Subjects who have consumed the following foods or drinks within 7 days prior to the first dose of study medication or at any time during the clinical phase of the study: grapefruit juice; red wine; grapefruit or cruciferous vegetables (watercress, broccoli, cabbage, Brussels sprouts).
  • QTc ≥ 450 msec at screening.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00537654

Locations
United States, Indiana
GSK Investigational Site
Evansville, Indiana, United States, 47714
United States, Texas
GSK Investigational Site
Austin, Texas, United States, 78752
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00537654     History of Changes
Other Study ID Numbers: ARI109882
Study First Received: September 28, 2007
Last Updated: October 13, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
benign prostatic hyperplasia,
AVODART,
FLOMAX

Additional relevant MeSH terms:
Prostatic Hyperplasia
Hyperplasia
Prostatic Diseases
Genital Diseases, Male
Pathologic Processes
Dutasteride
5-alpha Reductase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Urological Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 26, 2014