A Study To Compare Giving AVODART And FLOMAX Together Or In A Combination Capsule In The Fed And Fasted State
Information source: GlaxoSmithKline
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Benign Prostatic Hyperplasia
Intervention: GI198745 (Drug)
Phase: Phase 1
Sponsored by: GlaxoSmithKline
Official(s) and/or principal investigator(s):
GSK Clinical Trials, MD, Study Chair, Affiliation: GlaxoSmithKline
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.
Official title: 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
Study design: Treatment, Randomized, Open Label, Dose Comparison, Crossover Assignment, Bio-equivalence Study
Primary outcome: PK at 0,1,2,3,4,5,6,7,8,10,12,16,24,36,48,72
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,
Minimum age: 18 Years.
Maximum age: 45 Years.
- 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
- 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
- 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.
Locations and Contacts
GSK Clinical Trials Call Center, Evansville, Indiana 47714, United States
GSK Clinical Trials Call Center, Austin, Texas 78752, United States
Starting date: October 2007
Ending date: February 2008
Last updated: April 15, 2008