Comparative Bioavailability of Two Fixed Dose Combination (FDC) Formulations of Dutasteride and Tamsulosin Hydrochloride Relative to Co-administration of Dutasteride With Tamsulosin Hydrochloride in Healthy Male Subjects Under Fed and Fasted States

Inclusion Criteria:

- Males aged between 18 and 65 years of age inclusive, at the time of signing the
informed consent.

- Healthy as determined by a responsible and experienced physician, based on a medical
evaluation including medical history, physical examination, laboratory tests and
cardiac monitoring. A subject with a clinical abnormality or laboratory parameter(s)
which is/are not specifically listed in the inclusion or exclusion criteria, outside
the reference range for the population being studied may be included only if the
Investigator, in consultation with the GSK Medical Monitor if required, agree and
document that the finding is unlikely to introduce additional risk factors and will
not interfere with the study procedures.

- Body weight >=50 kilogram (kg) and body mass index (BMI) within the range 18 - 32
kg/m^2 (square meter) (inclusive).

- Male subjects with female partners of child-bearing potential must agree to use a
condom. This criterion must be followed from the time of the first dose of study
medication until 50 days post-last dose.

- Capable of giving written informed consent, which includes compliance with the
requirements and restrictions listed in the consent form.

- Able to swallow and retain oral medication.

- Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) <2x (Upper limit
of normal) ULN; alkaline phosphatase and bilirubin <=1.5xULN (isolated bilirubin
>1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).

- Based on single or averaged corrected QT (QTc) values of triplicate electrocardiograms
(ECGs) obtained over a brief recording period: QT duration corrected for heart rate by
Fridericia's formula (QTcF) <450 milliseconds (msec)

Exclusion Criteria:

Criteria Based Upon Medical Histories

- Current or chronic history of liver disease, or known hepatic or biliary abnormalities
(with the exception of Gilbert's syndrome or asymptomatic gallstones).

- History of sensitivity to any of the study medications, or components thereof or a
history of drug or other allergy that, in the opinion of the investigator or
GlaxoSmithKline (GSK) Medical Monitor, contraindicates their participation.

- History of postural hypotension, dizziness, poor hydration, vertigo, vaso-vagal
reactions or any other signs and symptoms of orthostasis, which in the opinion of the
investigator could be exacerbated by tamsulosin and result in putting the subject at
risk of injury.

- History of regular alcohol consumption within 6 months of the study defined for US
sites as: an average weekly intake of >14 drinks for males or >7 drinks for females.
One drink is equivalent to 12 gram (g) of alcohol: 12 ounces (360 millilitre [mL]) of
beer, 5 ounces (150 mL) of wine or 1.5 ounces (45 mL) of 80 proof distilled spirits.

- History of diabetes or peptic ulcer disease which is uncontrolled by medical
management.

- History of breast cancer or clinical breast examination finding suggestive of
malignancy. History of malignancy within the past five years, except for basal cell
carcinoma of the skin. Subjects with a prior malignancy who have had no evidence of
disease for at least the past 5 years are eligible.

- Prior medical history or evidence of prostate cancer (e.g., positive biopsy, or
suspicious ultrasound, or suspicious digital rectal examination [DRE]). Patients with
suspicious ultrasound or DRE who have had a negative biopsy within the preceding 6
months and stable prostate specific antigen (PSA) are eligible for the study. Note:
The investigator should make every appropriate effort to exclude the possibility of
prostate cancer, including consideration of prostate biopsy in any subject with a
known abnormal PSA.

Criteria Based Upon Diagnostic Assessments

- A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody
result within 3 months of screening;

- A positive pre-study drug/alcohol screen.

- A positive test for Human Immunodeficiency Virus (HIV) antibody. Other Criteria

- Where participation in the study would result in donation of blood or blood products
in excess of 500 mL within a 56 day period.

- The subject has participated in a clinical trial and has received an investigational
product within the following time period prior to the first dosing day in the current
study: 30 days, 5 half-lives or twice the duration of the biological effect of the
investigational product (whichever is longer).

- Exposure to more than four new chemical entities within 12 months prior to the first
dosing day.

- Unable to refrain from the use of prescription or non-prescription drugs, including
vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or
14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is
longer) prior to the first dose of study medication, unless in the opinion of the
Investigator and GSK Medical Monitor the medication will not interfere with the study
procedures or compromise subject safety.