Bioequivalence - Duodart Against Avodart & Omnic

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01657851
First received: August 2, 2012
Last updated: March 7, 2013
Last verified: March 2013
  Purpose

Open-label, randomized, single dose, two-treatment, two-way crossover study


Condition Intervention Phase
Prostatic Hyperplasia
Drug: dutasteride/tamsulosin
Drug: dutasteride
Drug: tamsulosin
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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 [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • to evaluate the safety and tolerability of the Combination Capsule formulation of dutasteride 0.5 mg/ tamsulosin HCl 0.4 mg [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
    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


Enrollment: 35
Study Start Date: August 2012
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: dutasteride/tamsulosin
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.
Drug: dutasteride/tamsulosin
Duodart® 0.5 mg / 0.4 mg - 1 dose at Day 1 of each treatment period. There are 2 treatment periods separated by approximately a 28-day washout period. All study drugs will be administered orally as capsules
Other Name: Duodart® 0.5 mg / 0.4 mg
Active Comparator: dutasteride
Dutasteride (Avodart®) is an approved potent dual type I and II, 5-alpha-reductase inhibitor indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to improve symptoms, reduce the risk of acute urinary retention and reduce the risk of the need for BPH-related surgery.
Drug: dutasteride
Avodart® 0.5 mg together with Omnic® 0.4 mg - 1 dose at Day 1 of each treatment period. There are 2 treatment periods separated by approximately a 28-day washout period. All study drugs will be administered orally as capsules
Other Name: Avodart® 0.5 mg
Drug: tamsulosin
Omnic® 0.4 mg together with Avodart® 0.5 mg - 1 dose at Day 1 of each treatment period. There are 2 treatment periods separated by approximately a 28-day washout period. All study drugs will be administered orally as capsules
Other Name: Omnic® 0.4 mg
Active Comparator: tamsulosin
Tamsulosin (Omnic®) is an alpha-1A-adrenocepter blocking agent approved for the treatment of signs and symptoms of benign prostatic hyperplasia
Drug: dutasteride
Avodart® 0.5 mg together with Omnic® 0.4 mg - 1 dose at Day 1 of each treatment period. There are 2 treatment periods separated by approximately a 28-day washout period. All study drugs will be administered orally as capsules
Other Name: Avodart® 0.5 mg
Drug: tamsulosin
Omnic® 0.4 mg together with Avodart® 0.5 mg - 1 dose at Day 1 of each treatment period. There are 2 treatment periods separated by approximately a 28-day washout period. All study drugs will be administered orally as capsules
Other Name: Omnic® 0.4 mg

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01657851

Locations
Russian Federation
GSK Investigational Site
Reutov, Moscow Region, Russian Federation, 143964
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01657851     History of Changes
Other Study ID Numbers: 116502
Study First Received: August 2, 2012
Last Updated: March 7, 2013
Health Authority: Russia: Roszdrav Nadzor
Russia: Ministry of Health of the Russian Federation

Additional relevant MeSH terms:
Prostatic Hyperplasia
Hyperplasia
Prostatic Diseases
Genital Diseases, Male
Pathologic Processes
Tamsulosin
Dutasteride
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
5-alpha Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on April 15, 2014