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
Alfred Hospital, 87 Commercial Road
Melbourne VIC, 3004
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
This study involves 3 drugs called MK-0906A, Proscar and Tamsulosin intended for treatment of benign prostate hyperplasia (BPH). BPH is a very common medical condition in most men above 50 years of age and is characterised by enlarged prostate gland resulting in difficulty in urination.
This study is testing and comparing the safety, tolerability and pharmacokinetics (level of drug in your blood) of a single dose of MK-0906A, Tamsulosin and Proscar in different treatment combinations and sequence.
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
[email protected]
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
[email protected]

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.