Bioequivalence - Duodart Against Avodart & Omnic

Launched by GLAXOSMITHKLINE · Aug 2, 2012

Keywords

ClinConnect Summary

The present study is planned to establish bioequivalence of Duodart® 0.5mg/0.4mg manufactured by GlaxoSmithKline to concomitant dosing with separate capsules of dutasteride 0.5 mg and tamsulosin hydrochloride 0.4 mg formulations commercially available in Russia. The design of the present study relies on data obtained in pivotal bioequivalence study and Russian guidance on high quality bioequivalence studies.

Summary of treatment groups Treatment Sequence Number of subjects

1. 18
2. 18 Total number of subjects 36 Eligible subjects will be admitted to the research unit one day prior to dosi...

Gender

MALE

Eligibility 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