Prostatic Hyperplasia Clinical Trial
Official title:
An Open-Label, Randomized, Single Dose Crossover Study to Determine the Bioequivalence of Duodart® 0.5mg/0.4mg (Capsule Formulation of Dutasteride 0.5mg and Tamsulosin Hydrochloride 0.4mg) Compared to Concomitant Dosing of Avodart® 0.5mg and Omnic® 0.4mg Commercial Capsules in Healthy Male Subjects.
Verified date | June 2017 |
Source | GlaxoSmithKline |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Open-label, randomized, single dose, two-treatment, two-way crossover study
Status | Completed |
Enrollment | 35 |
Est. completion date | December 5, 2012 |
Est. primary completion date | December 5, 2012 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years to 45 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Russian Federation | GSK Investigational Site | Reutov, Moscow Region |
Lead Sponsor | Collaborator |
---|---|
GlaxoSmithKline |
Russian Federation,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | bioequivalence of a Combination Capsule formulation of dutasteride 0.5 mg/ tamsulosin HCl 0.4 mg (Duodart® 0.5 mg/ 0.4 mg fixed combination) relative to concomitant dosing of Avodart® 0.5 mg and the Omnic® 0.4 | Dutasteride and tamsulosin will be extracted from human plasma by liquid-liquid extraction using organic solvent. Extracts will be analysed by validated high-performance liquid chromatography - mass spectrometry. The lower limit of detection is about 0.1ng/mL | 2 months | |
Secondary | to evaluate the safety and tolerability of the Combination Capsule formulation of dutasteride 0.5 mg/ tamsulosin HCl 0.4 mg | The following safety parameters will be assessed during the study: Physical examination; Orthostatic vital signs; Vital signs; 12-lead ECG; Adverse events; Serum chemistry; Complete blood count | 2 months |
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