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.

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

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12611001047987

Enrollment

Registered

2011-10-05

Start date

2011-12-15

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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.

Study design

Allocation

Randomised controlled trial

Primary purpose

Treatment

Eligibility

Sex/Gender

Male

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

Healthy Caucasian Male subjects who have been non smoker for at least 6 months

Exclusion criteria

History of malignancy, Human Immunodeficiency Virus (HIV), Hepatitis B, Hepatitis C or other clinically significant disease, as specified.

Outcome results