Last updated: 11/07/2018 15:32:00
A double blind, randomized and placebo-controlled parallel group study to evaluate the safety and pharmacokinetics/pharmacodynamics of a single oral 0.5mg dose of dutasteride in healthy Korean male volunteers.
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A double blind, randomized and placebo-controlled parallel group study to evaluate the safety and pharmacokinetics/pharmacodynamics of a single oral 0.5mg dose of dutasteride in healthy Korean male volunteers.
Trial description: A double blind, randomized and placebo-controlled parallel group study to evaluate the safety and pharmacokinetics/pharmacodynamics of a single oral 0.5mg dose of dutasteride in healthy Korean male volunteers.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
Not applicable
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Abstract: Effect of srd5a2 genotype on pharmacodynamics of 5-alpha-reductase inhibitor analyzed by pk-pd modeling. Chung, J. MD, Cho, J. PhD, Lim, H. MD, Oh, D. OMD, Yi, S. MS, Jang, I. MD PhD, and Shin, S. MD PhD 105th Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics 3/24/2004 Miami Beach, FL; USA
Medical condition
Urologic Diseases
Product
dutasteride
Collaborators
Not applicable
Study date(s)
N/A to Invalid Date
Type
Not applicable
Phase
1
Participation criteria
Sex
Not applicable
Age
Not applicable
Accepts healthy volunteers
Not applicable
Inclusion and exclusion criteria
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Not applicable
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
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
Not applicable
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