A Study To Compare Giving AVODART And FLOMAX Together Or In A Combination Capsule In The Fed And Fasted State
A Study To Compare Giving AVODART And FLOMAX Together Or In A Combination Capsule In The Fed And Fasted State
This study will be an open-label, randomized, single dose, three way partial crossover study
 in healthy male subjects. The aim of the study is to evaluate bioequivalence of a fixed dose
 combination (FDC) capsule of dutasteride and tamsulosin hydrochloride (HCl) (0.5 milligram
 [mg]/0.4 mg) relative to co-administration of dutasteride 0.5 mg capsules and tamsulosin
 hydrochloride 0.4 mg tablets in both the fed and fasted states. Approximately 98 healthy
 adult male subjects will be enrolled into the study. Subjects will receive single oral doses
 in 3 treatment periods and be randomized to one of twelve different treatment sequences (ABC,
 ACB, BAC, BCA, CAB, CBA, ABD, ADB, BAD, BDA, DAB, DBA) wherein A= commercially available
 tamsulosin hydrochloride 0.4 mg and dutasteride 0.5 mg in a fed state, B= fixed dose
 combination formulation of dutasteride and tamsulosin hydrochloride (0.5 mg dutasteride, 0.4
 mg tamsulosin hydrochloride) in a fed state, C= commercially available tamsulosin
 hydrochloride 0.4 mg and dutasteride 0.5 mg in a fasted state, D= fixed dose combination
 formulation of dutasteride and tamsulosin hydrochloride (0.5 mg dutasteride, 0.4 mg
 tamsulosin hydrochloride) in a fasted state. Each treatment period will be separated by a
 minimum 28 day washout period. The total duration of a subject's involvement in this study is
 approximately 15-18 weeks.
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
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.