Last updated: 11/04/2018 04:45:09

A Study To Compare 3 Different Formulations Of Tamsulosin At Steady State.

GSK study ID
ARI111402
Clinicaltrials.gov ID
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, repeat dose, 3 period crossover study to determine the bioequivalence of 3 different formulations of tamsulosin at steady state in healthy male volunteers
Trial description: Dutasteride and tamsulosin are to treat benign prostatic hyperplasia. Studies show that when given together, there is more improvement in symptoms than either drug alone. In this study, we are looking to see if 2 different formulations of tamsulosin in our combination capsules are the same after 7 days of dosing as the US commercial tamsulosin and dutasteride.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

PK at 0,1,2,3,4,5,6,7,8,10,12,16,24,36,48,72

Timeframe: n/a

Secondary outcomes:

Clinical safety labs

Timeframe: at check in

measurement of orthostatic hypotension

Timeframe: at 6 hours post dose on days 1 and 7

adverse event reporting

Timeframe: n/a

C(tau) (pre-dose concentrations determined immediately before a dose at steady state), t1/2, tmax, lambda, Cmin and fluctuation [(Cmax - Cmin)/(AUC(0-24)/24)] of tamsulosin, as data permit.

Timeframe: n/a

Safety and tolerability of all treatments as assessed by blood pressure and pulse rate measurements, adverse events and clinical laboratory safety tests.

Timeframe: n/a

Interventions:
Drug: GI198745
Enrollment:
24
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Gengqian. Cai, J.J. Thiessen, Charlotte.A. Baidoo, and Michael.J. Fossler. Operating characteristics of a partial-block randomized crossover bioequivalence study for dutasteride, a drug with a long half-life: investigation through simulation and comparison with final results. J Clin Pharm. 2010;50(10):1142-50.
Medical condition
Prostatic Hyperplasia
Product
dutasteride
Collaborators
Not applicable
Study date(s)
February 2008 to April 2008
Type
Interventional
Phase
1

Participation criteria

Sex
Male
Age
18 - 45 years
Accepts healthy volunteers
Yes
  • Healthy as determined by a responsible physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator and the GSK Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures. Subjects with orthostasis at screening should be excluded from enrollment.
  • Males between 18 and 45 years of age (inclusive).
  • The subject has a positive pre-study drug/alcohol screen. A minimum list of drugs that will be screened for include amphetamines, barbiturates, cocaine, opiates, cannabinoids and benzodiazepines.
  • Slow metabolizer for CYP2D6 as determined by screening PGx analysis.

Trial location(s)

Location
Status
Contact us
Contact us
Location
GSK Investigational Site
Buffalo, New York, United States, 14202
Status
Will Be Recruiting

Study documents

Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English

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
Not applicable
Actual study completion date
2008-23-04

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

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Additional information
Results for study ARI111402 can be found on the GSK Clinical Study Register.
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