Overview
Bioequivalence - Duodart Against Avodart & Omnic
Status:
Completed
Completed
Trial end date:
2012-12-05
2012-12-05
Target enrollment:
0
0
Participant gender:
Male
Male
Summary
Open-label, randomized, single dose, two-treatment, two-way crossover studyPhase:
Phase 1Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
GlaxoSmithKlineTreatments:
Dutasteride
Tamsulosin
Criteria
Inclusion Criteria:- Willing and able to give written informed consent
- Males who are 18 - 45 years of age, inclusive
- Verified diagnosis "healthy"
- Body mass index 20-25 kg/m2 (inclusive)
- Negative results of test for HIV, syphilis, hepatitis B (HBs Ag) and hepatitis C
- Adequate, liver, and renal function
- adequate contraception
Exclusion Criteria:
- Poor metabolizer for CYP2D6
- Medical history of allergy
- Medical history of medicines intolerability
- Chronic diseases
- History of surgery on gastrointestinal tract
- History of prostate cancer
- History of breast cancer
- Acute infectious disease
- Regular use of drugs
- Intake of medicines with high influence on liver function or haemodynamics
- Use of drugs that influence activity of CYP2D6 and CYP3A4
- Use of Dutasteride less than 6 months before study entry or alpha-blockers less than 2
weeks before study entry
- Blood donation (≥450 mL of blood or plasma) less than 2 months before study start
- History of regular alcohol consumption
- A positive urine drug or alcohol
- Smoking more than 10 cigarettes a day
- Participation in Phase I clinical trials less than 3 months before study entry
- History of postural hypotension, dizziness, poor hydration, vertigo, vaso-vagal
reactions or any other signs and symptoms of orthostasis
- 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