Bioavailability Study of Fixed Dose Combination (FDC) Dutasteride and Tamsulosin Hydrochloride (HCl) Relative to One Dutasteride and One Tamsulosin HCl Tablet in Healthy Male Subjects

Inclusion Criteria:

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

- Healthy as determined by the investigator or medically qualified designee 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 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 to 30 kg
per meter square (m^2) (inclusive).

- Capable of giving signed informed consent which includes compliance with the
requirements and restrictions listed in the consent form and in this protocol.

Exclusion Criteria:

- Alanine aminotransferase (ALT) and bilirubin >1.5xUpper limit of normal (ULN)
(isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct
bilirubin <35 percent).

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

- Current or history of: Breast cancer or clinical breast examination finding suggestive
of breast malignancy; 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.

- Based on averaged corrected QT (QTc) values of triplicate ECGs obtained over a brief
recording period: QTcF > 450 millisecond (msec).

- Subjects must abstain from taking prescription or non-prescription drugs (including
vitamins and dietary or herbal supplements), 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 until completion of the follow-up visit, unless in the
opinion of the Investigator and sponsor the medication will not interfere with the
Study.

- History of regular alcohol consumption within 6 months of the study defined as: For
United States sites: 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 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 Medical
Monitor, contraindicates their participation.

- Presence of hepatitis B surface antigen (HBsAg), positive hepatitis C antibody test
result at screening or within 3 months prior to first dose of study treatment.

- A positive pre-study drug/alcohol screen.

- A positive test for human immunodeficiency virus (HIV) antibody.

- Where participation in the study would result in donation of blood or blood products
in excess of 500 mL over the duration of the study.

- 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: 50 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 swallow and retain oral medication.