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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

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Prostatic Hyperplasia

Intervention: FDC capsule of dutasteride and tamsulosin (Drug); Dutasteride soft gelatine capsule and tamsulosin HCl oral disintegrating tablet (Drug)

Phase: Phase 1

Status: Not yet recruiting

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

Overall contact:
US GSK Clinical Trials Call Center, Phone: 877-379-3718, Email: GSKClinicalSupportHD@gsk.com


The primary objective of this study is to determine the bioavailability of a FDC capsule formulation of dutasteride and tamsulosin hydrochloride (0. 5 milligram [mg]/0. 2 mg) relative to coadministration of one dutasteride 0. 5 mg capsule and one tamsulosin HCl 0. 2 mg tablet in healthy male subjects in fed and fasted states. This is an open-label, randomized, single dose, two-way crossover study enrolling healthy male subjects, split into fasted (Cohort 1) and fed (Cohort 2) conditions. In both cohorts, one FDC capsule formulation of dutasteride 0. 5 mg/tamsulosin HCl 0. 2 mg will be administered in one treatment period and the coadministration of dutasteride and tamsulosin hydrochloride in a different treatment period. Each subject enrolled will be allowed to participate in only one cohort (i. e, will receive treatment under fasted or fed conditions) and will participate in both treatment periods. The two treatment periods will be separated by a minimum washout period of 28 days. The total duration in the study for each subject will be approximately 2. 5 months from screening to the final follow-up visit.

Clinical Details

Official title: An Open-label, Randomized, Single Dose, Two-way Crossover Study to Determine the Bioavailability of One Fixed Dose Combination Capsule Formulation of Dutasteride and Tamsulosin Hydrochloride (0.5 mg/0.2 mg) Relative to Coadministration of One Dutasteride 0.5 mg Capsule and One Tamsulosin Hydrochloride 0.2 mg Tablet in Healthy Male Subjects in the Fed and Fasted States

Study design: Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Maximum observed serum concentration (Cmax) for dutasteride and tamsulosin

Area under the serum concentration-time curve (AUC) zero to time 't' (AUC[0-t]) for tamsulosin and dutasteride; AUC 0 to infinity (AUC 0-inf) will be determined for tamsulosin as data permit

Secondary outcome:

Time of occurrence of Cmax (Tmax) for dutasteride and tamsulosin

Terminal phase half-life (t1/2) for tamsulosin

Number of participants with adverse events (AE) /serious adverse event (SAE) as a measure of safety and tolerability

Composite of vital signs as a measure of safety and tolerability

Composite of 12-lead electrocardiogram (ECG) assessment as a safety measure


Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Male.


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


- 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.

Locations and Contacts

US GSK Clinical Trials Call Center, Phone: 877-379-3718, Email: GSKClinicalSupportHD@gsk.com

GSK Investigational Site, Baltimore, Maryland 21225, United States; Not yet recruiting
US GSK Clinical Trials Call Center, Phone: 877-379-3718, Email: GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Center, Phone: +44 (0) 20 8990 4466, Email: GSKClinicalSupportHD@gsk.com
Additional Information

Starting date: July 2015
Last updated: July 30, 2015

Page last updated: August 23, 2015

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