Last updated: 09/03/2020 09:40:05

Bioequivalence - Duodart against Avodart & Omnic

GSK study ID
116502
See study documents
Clinicaltrials.gov ID
NCT01657851
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

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.
Trial description: Open-label, randomized, single dose, two-treatment, two-way crossover study
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

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

Timeframe: 2 months

Secondary outcomes:

to evaluate the safety and tolerability of the Combination Capsule formulation of dutasteride 0.5 mg/ tamsulosin HCl 0.4 mg

Timeframe: 2 months

Interventions:
Drug: dutasteride/tamsulosin
Drug: dutasteride
Drug: tamsulosin
Enrollment:
35
Observational study model:
Not applicable
Primary completion date:
2012-05-12
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Prostatic Hyperplasia
Product
dutasteride, dutasteride/tamsulosin, tamsulosin
Collaborators
Not applicable
Study date(s)
August 2012 to December 2012
Type
Interventional
Phase
1

Participation criteria

Sex
Male
Age
18 - 45 years
Accepts healthy volunteers
Yes
  • Willing and able to give written informed consent
  • Males who are 18 - 45 years of age, inclusive
  • Poor metabolizer for CYP2D6
  • Medical history of allergy
Inclusion and exclusion 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

Trial location(s)

Location
Status
Contact us
Contact us
Location
GSK Investigational Site
Reutov, Moscow Region, Russia, 143964
Status
Study Complete
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Study documents

Protocol
Available language(s): English
Download document(s)
Scientific result summary
Available language(s): English
Download document(s)

If you wish to request for full study report, please contact - [email protected]

Results overview

Refer to study documents

Recruitment status
Completed
Actual primary completion date
2012-05-12
Actual study completion date
2012-05-12

Plain language summaries

Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

Additional information about the trial

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Additional information
Results for study 116502 can be found on the GSK Clinical Study Register.
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