Prostatic Hyperplasia
Conditions
Keywords
Bioavailability, Dutasteride, Healthy Male Subjects, Fixed Dose Combination
Brief summary
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.
Interventions
DRUGFDC capsule of dutasteride and tamsulosin
Each FDC capsule contains a mixture of dutasteride formulation (equivalent to 0.5 mg dutasteride) and tamsulosin (equivalent to 0.2 mg tamsulosin) and its physical appearance is hard shell capsule.
DRUGDutasteride soft gelatine capsule and tamsulosin HCl oral disintegrating tablet
Coadministration of dutasteride soft gelatine capsule and tamsulosin HCl oral disintegrating tablet. Each soft gelatine capsule consist of 0.5 mg of dutasteride and physical appearance is Oblong, size 6, dull yellow capsule. Each oral disintegrating tablet consist of 0.2 mg of tamsulosin and its physical appearance is white, round standard convex.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum observed serum concentration (Cmax) for dutasteride and tamsulosin | Days 1 to 4 of both treatment periods | Blood samples for PK analysis will be collected for each subject at the following time points: Pre-dose, 15 minutes (min), 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48 & 72 hours post dose in both the treatment periods. Cmax will be determined for tamsulosin and dutasteride. |
| 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 | Days 1 to 4 of both treatment periods | Blood samples for PK analysis will be collected for each subject at the following time points: Pre-dose, 15 minutes (min), 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48 & 72 hours post dose in both the treatment periods. AUC 0-t will be determined for tamsulosin and dutasteride. Additionally, AUC 0-inf will be determined for tamsulosin as data permit. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with adverse events (AE) /serious adverse event (SAE) as a measure of safety and tolerability | From start of study treatment until follow-up contact (up to Week 7) | AEs and SAEs will be collected from the start of study Treatment until the follow-up contact. |
| Time of occurrence of Cmax (Tmax) for dutasteride and tamsulosin | Days 1 to 4 of both treatment periods | Blood samples for PK analysis will be collected for each subject at the following time points: Pre-dose, 15 minutes (min), 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48 & 72 hours post dose in both the treatment periods. Tmax will be determined for tamsulosin and dutasteride. |
| Composite of 12-lead electrocardiogram (ECG) assessment as a safety measure | Screening, Day 1 and Day 2 in both treatment periods and follow-up visit (up to 2.5 months). | ECG measurement include heart rate and measures PR, QRS, QT, and QT interval corrected using the Fridericia's formula (QTcF) intervals. |
| Composite of vital signs as a measure of safety and tolerability | Screening visit, Day -1, and Day 2 (in both treatment periods) and follow-up visit (up to 2.5 months). | Vital signs will be measured in semi-supine position after 5 minutes rest and will include temperature, systolic and diastolic blood pressure and pulse rate. |
| Terminal phase half-life (t1/2) for tamsulosin | Days 1 to 4 of both treatment periods | Blood samples for PK analysis of tamsulosin and dutasteride will be collected for each subject at the following time points: Pre-dose, 15 minutes (min), 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48 & 72 h post dose in both the treatment periods. Terminal phase half-life will be determined for tamsulosin. |
Countries
United States
Outcome results
None listed