Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611001047987
Ethics application status
Not yet submitted
Date submitted
29/09/2011
Date registered
5/10/2011
Date last updated
5/10/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
A formulation comparison study in Healthy Volunteers to compare the pharmacokinetic of Tamsulosin Hydrochloride and Proscar (registered) when administered as part of a fixed dose combination to when they are administered separately as single doses.
Scientific title
Healthy Volunteers Study: A Single Dose Study to Compare the Pharmacokinetics of a Fixed-Dosed Combination Formulation of Proscar (Finasteride) and an Alpha-Blocker Inhibitor to Co-Admnistered Proscar and an Alpha-Blocker Inhibitor and to Assess the Potential Drug-Drug Interaction between Proscar and an Alpha-Blocker
Secondary ID [1] 273130 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Formulation Comparison study 270887 0
Condition category
Condition code
Other 279060 279060 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Subjects randomised to either Part 1 or Part 2 will receive the treatments listed below in an open-label, randomised, crossover manner:

Part 1
Volunteers will receive 2 treatments with at least 5 days in between Treatment A: oral single capsule of MK-906A (fixed dose combination of 0.2mg Tamsulosin Hydrochloride and 5mg Proscar) & Treatment B: oral single 0.2mg capsule of tamsulosin hydrocholoride+oral single tablet 5mg Proscar (finasteride).
The sequence in which the volunteers will receive the drug will be different and allocated randomly.

Part 2 :
Volunteers will receive 3 treatments with at least 5 days in between of Treatment C:oral single capsule 0.2mg tamsulosin hydrochloride+ oral single tablet 5 mg Proscar (Finasteride); Treatment D: oral single capsule 0.2 mg tamsulosin hydrochloride; Treatment E: oral single tablet 5 mg Proscar (finasteride). The sequence in which the volunteers will receive the drug will be different and allocated randomly.
Intervention code [1] 269471 0
Treatment: Drugs
Comparator / control treatment
There is no active comparator or control treatment as this study is a formulation comparison study.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 279709 0
To compare the single dose pharmacokinetic (level of drug in your blood) profile of Proscar following administration of MK-906A and co-admnistration of corresponding doses of Proscar and tamsulosin hydrochloride as individual tablets. Bioanalytical assay of drug levels in blood.
Timepoint [1] 279709 0
11 timepoints at irregular frequency up to 36 hours postdose.
Secondary outcome [1] 294270 0
To compare the single dose pharmacokinetic (level of drug in your blood) profile of tamsulosin hydrochloride following administration of MK-906A and co-admnistration of corresponding doses of Proscar and tamsulosin hydrochloride as individual tablets. Bioanalytical assay of drug levels in blood.
Timepoint [1] 294270 0
12 timepoints at irregular frequency up to 48 hours postdose.

Eligibility
Key inclusion criteria
Healthy Caucasian Male subjects who have been non smoker for at least 6 months
Minimum age
18 Years
Maximum age
55 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
History of malignancy, Human Immunodeficiency Virus (HIV), Hepatitis B, Hepatitis C or other clinically significant disease, as specified.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/12/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
36
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 269950 0
Commercial sector/Industry
Name [1] 269950 0
Merck Sharp & Dohme corp, a subsidiary of Merck & Co. Inc
Country [1] 269950 0
United States of America
Funding source category [2] 269974 0
Commercial sector/Industry
Name [2] 269974 0
Merck Sharp & Dohme corp., a subsidiary of Merck & Co. Inc
Country [2] 269974 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Merck Sharp & Dohme corp., a subsidiary of Merck & Co. Inc
Address
P.O. Box 100
Whitehouse Station, NJ, 0889-0100
Country
United States of America
Secondary sponsor category [1] 268975 0
None
Name [1] 268975 0
Address [1] 268975 0
Country [1] 268975 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 271919 0
Research Ethics Unit, Alfred Hospital
Ethics committee address [1] 271919 0
Ethics committee country [1] 271919 0
Australia
Date submitted for ethics approval [1] 271919 0
05/10/2011
Approval date [1] 271919 0
Ethics approval number [1] 271919 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33214 0
Address 33214 0
Country 33214 0
Phone 33214 0
Fax 33214 0
Email 33214 0
Contact person for public queries
Name 16461 0
Assoc Prof Peter Hodsman
Address 16461 0
Level 5 Burnet Institute, AMREP Precinct , 89 Commercial Road, Victoria 3004, Australia
Country 16461 0
Australia
Phone 16461 0
+61 3 9076 8960
Fax 16461 0
Email 16461 0
p.hodsman@nucleusnetwork.com.au
Contact person for scientific queries
Name 7389 0
Assoc Prof Peter Hodsman
Address 7389 0
Level 5 Burnet Institute, AMREP Precinct, 89 Commercial Road, Victoria 3004, Australia
Country 7389 0
Australia
Phone 7389 0
+61 3 9076 8960
Fax 7389 0
Email 7389 0
p.hodsman@nucleusnetwork.com.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.