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
Study complete
Study complete
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
    Primary completion date:
    2012-05-12
    Observational study model:
    Not applicable
    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
    Contact us

    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
    Study complete
    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

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