Last updated: 11/07/2018 15:40:40
An Open-label, Crossover Study to Investigate the Pharmacokinetic-Pharmacodynamic Interaction Between (1) Tamsulosin and GI198745(dutasteride) and (2) Terazosin and GI198745 (dutasteride) When Co-administered to Healthy Male Subjects for 14 Days
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: An Open-label, Crossover Study to Investigate the Pharmacokinetic-Pharmacodynamic Interaction Between (1) Tamsulosin and GI198745(dutasteride) and (2) Terazosin and GI198745 (dutasteride) When Co-administered to Healthy Male Subjects for 14 Days
Trial description: An Open-label, Crossover Study to Investigate the Pharmacokinetic-Pharmacodynamic Interaction Between (1) Tamsulosin and GI198745(dutasteride) and (2) Terazosin and GI198745 (dutasteride) When Co-administered to Healthy Male Subjects for 14 Days
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: No evidence of drug interactions between g1198745, a novel dual 5 alpha reductase, inhibitor, and alpha i adrenergic antagonists. Richard V Clark, Lynda J. Haberer John R. Horton Christine D. Foster. 95th Annual Meeting of the American Urological Association 4/29/2000
Abstract: The dual 5 alpha-reductase inhibitor dutasteride is well tolerated and has no effect on the pharmacokinetic profiles of tamsulosin or terazosin when used in combination in healthy male volunteers. Clark, R. and Haberer, L. 20th Congress of the European Association of Urology 3/16/2005 Istanbul; Turkey
Clark RV, Haberer LJ, Horton JR, Forster CD. No evidence of drug interactions between GI198745, a novel dual 5 alpha-reductase inhibitor, and alpha 1-adrenergic antagonists. Journal of Urology 1999; 163 (S4): 975
Clark RV, Walls RG. The dual 5ARI dutasteride is well tolerated and has no effect on the pharmacokinetic profiles of tamsulosin or terazosin when used in combination in healthy male volunteers. SIU 2004 (to be published following the annual congress in October 2004)
Medical condition
Prostatic Hyperplasia
Product
dutasteride
Collaborators
Not applicable
Study date(s)
September 1998 to April 1999
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
1999-15-04
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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