A Study To Compare Giving AVODART And FLOMAX Together Or In A Combination Capsule In The Fed And Fasted State
- Conditions
- Prostatic Hyperplasia
- Interventions
- Drug: Treatment sequence CDrug: Treatment sequence ADrug: Treatment sequence B
- Registration Number
- NCT00537654
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
This study will be an open-label, randomized, single dose, three way partial crossover study in healthy male subjects. The aim of the study is to evaluate bioequivalence of a fixed dose combination (FDC) capsule of dutasteride and tamsulosin hydrochloride (HCl) (0.5 milligram \[mg\]/0.4 mg) relative to co-administration of dutasteride 0.5 mg capsules and tamsulosin hydrochloride 0.4 mg tablets in both the fed and fasted states. Approximately 98 healthy adult male subjects will be enrolled into the study. Subjects will receive single oral doses in 3 treatment periods and be randomized to one of twelve different treatment sequences (ABC, ACB, BAC, BCA, CAB, CBA, ABD, ADB, BAD, BDA, DAB, DBA) wherein A= commercially available tamsulosin hydrochloride 0.4 mg and dutasteride 0.5 mg in a fed state, B= fixed dose combination formulation of dutasteride and tamsulosin hydrochloride (0.5 mg dutasteride, 0.4 mg tamsulosin hydrochloride) in a fed state, C= commercially available tamsulosin hydrochloride 0.4 mg and dutasteride 0.5 mg in a fasted state, D= fixed dose combination formulation of dutasteride and tamsulosin hydrochloride (0.5 mg dutasteride, 0.4 mg tamsulosin hydrochloride) in a fasted state. Each treatment period will be separated by a minimum 28 day washout period. The total duration of a subject's involvement in this study is approximately 15-18 weeks.
- Detailed Description
An Open-Label, Randomized, Single Dose Three-Period Partial Crossover Study to Determine the Bioequivalence and Food Effect of a Combination Capsule Formulation of Dutasteride and Tamsulosin Hydrochloride (0.5mg/0.4mg) Compared to Concomitant Dosing of AVODART 0.5mg and FLOMAX 0.4mg Commercial Capsules in Healthy Male Subjects
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 81
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Fasted state Treatment sequence C Subjects will be required to fast overnight. Subjects will participate in 3 treatment periods and assigned to one of 12 treatment sequences ( ABC, ACB, BAC, BCA, CAB, CBA, ABD, ADB, BAD, BDA, DAB, DBA) in accordance with the randomization schedule. The three treatment periods will be separated by a minimum washout period of 28 days Fed state Treatment sequence A Subjects will be served high fat breakfast 30 minutes prior to dosing. Subjects will participate in 3 treatment periods and assigned to one of 12 treatment sequences ( ABC, ACB, BAC, BCA, CAB, CBA, ABD, ADB, BAD, BDA, DAB, DBA) in accordance with the randomization schedule. The three treatment periods will be separated by a minimum washout period of 28 days Fed state Treatment sequence B Subjects will be served high fat breakfast 30 minutes prior to dosing. Subjects will participate in 3 treatment periods and assigned to one of 12 treatment sequences ( ABC, ACB, BAC, BCA, CAB, CBA, ABD, ADB, BAD, BDA, DAB, DBA) in accordance with the randomization schedule. The three treatment periods will be separated by a minimum washout period of 28 days Fasted state Treatment sequence D Subjects will be required to fast overnight. Subjects will participate in 3 treatment periods and assigned to one of 12 treatment sequences ( ABC, ACB, BAC, BCA, CAB, CBA, ABD, ADB, BAD, BDA, DAB, DBA) in accordance with the randomization schedule. The three treatment periods will be separated by a minimum washout period of 28 days
- Primary Outcome Measures
Name Time Method Area under the curve (AUC) from time zero to 24 hours (AUC[0-24]) of plasma tamsulosin in fed state Pre-dose and post dose at 1,2,3,4,5,6,7,8,10,12,16,24,36,48,72hrs Plasma samples will be collected at indicated time points
Area under the curve from time zero to infinity (AUC[0-inf]) of plasma tamsulosin in fed state Pre-dose and post dose at 1,2,3,4,5,6,7,8,10,12,16,24,36,48,72hrs Plasma samples will be collected at indicated time points
Concentration maximum (Cmax) of plasma tamsulosin in fed state Pre-dose and post dose at 1,2,3,4,5,6,7,8,10,12,16,24,36,48,72hrs Plasma samples will be collected at indicated time points
Area under the curve (AUC) from time zero to 72 hours (AUC[0-72]) of plasma dutasteride in fed state Pre-dose and post dose at 1,2,3,4,5,6,7,8,10,12,16,24,36,48,72hrs Plasma samples will be collected at indicated time points
Area under the curve (AUC) from time zero to 24 hours (AUC[0-24]) of plasma dutasteride in fed state Pre-dose and post dose at 1,2,3,4,5,6,7,8,10,12,16,24,36,48,72hrs Plasma samples will be collected at indicated time points
Area under the curve (AUC) from time zero to 24 hours (AUC[0-24]) of plasma tamsulosin in fasted state Pre-dose and post dose at 1,2,3,4,5,6,7,8,10,12,16,24,36,48,72hrs Plasma samples will be collected at indicated time points
Area under the curve from time zero to infinity (AUC[0-inf]) of plasma tamsulosin in fasted state Pre-dose and post dose at 1,2,3,4,5,6,7,8,10,12,16,24,36,48,72hrs Plasma samples will be collected at indicated time points
Concentration maximum (Cmax) of plasma tamsulosin in fasted state Pre-dose and post dose at 1,2,3,4,5,6,7,8,10,12,16,24,36,48,72hrs Plasma samples will be collected at indicated time points
Concentration maximum (Cmax) of plasma dutasteride in fed state Pre-dose and post dose at 1,2,3,4,5,6,7,8,10,12,16,24,36,48,72hrs Plasma samples will be collected at indicated time points
Area under the curve (AUC) from time zero to 24 hours (AUC[0-24]) of plasma dutasteride in fasted state Pre-dose and post dose at 1,2,3,4,5,6,7,8,10,12,16,24,36,48,72hrs Plasma samples will be collected at indicated time points
Area under the curve (AUC) from time zero to 72 hours (AUC[0-72]) of plasma dutasteride in fasted state Pre-dose and post dose at 1,2,3,4,5,6,7,8,10,12,16,24,36,48,72hrs Plasma samples will be collected at indicated time points
Concentration maximum (Cmax) of plasma dutasteride in fasted state Pre-dose and post dose at 1,2,3,4,5,6,7,8,10,12,16,24,36,48,72hrs Plasma samples will be collected at indicated time points
- Secondary Outcome Measures
Name Time Method Time to maximum observed plasma drug concentration (tmax) of tamsulosin and dutasteride Pre-dose and post dose at 1,2,3,4,5,6,7,8,10,12,16,24,36,48,72hrs Plasma samples will be collected at indicated time points
Elimination half-life (t1/2) of tamsulosin and dutasteride Pre-dose and post dose at 1,2,3,4,5,6,7,8,10,12,16,24,36,48,72hrs Plasma samples will be collected at indicated time points
Negative slope of the terminal phase of tamsulosin and dutasteride Pre-dose and post dose at 1,2,3,4,5,6,7,8,10,12,16,24,36,48,72hrs Plasma samples will be collected at indicated time points
Number of subjects with adverse event (AE) and serious adverse event (SAE). Up to 18 weeks AE is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgement will be categorized as SAE.
Number of subjects with abnormal clinical laboratory parameters Up to 18 weeks Blood samples will be collected to analyze aspartate aminotransferase (AST), alkaline Phosphatase (ALP), alanine aminotransferase (ALT), creatinine, blood urea nitrogen, creatine kinase, total bilirubin, direct bilirubin, total protein, albumin, glucose, sodium, potassium, calcium
Number of subjects with abnormal hematology laboratory parameters Up to 18 weeks Blood samples will be collected to analyze White Blood Cells (WBC), neutrophils, basophils, eosionophils, lymphocytes, monocytes, Red Blood Cells (RBC) count, RBC indices, Day -1average red blood cell size (MCV), hemoglobin amount per red blood cell (MCH) hemoglobin, hematocrit, and platelet count
Concentration minimum (Cmax) of plasma tamsulosin Pre-dose and post dose at 1,2,3,4,5,6,7,8,10,12,16,24,36,48,72hrs Plasma samples will be collected at indicated time points
Number of subjects with abnormal urinalysis Up to 18 weeks Urine samples will be collected to analyze specific gravity, pH, glucose, protein, blood and ketones
Blood pressure assessment as a measure of safety Up to 18 weeks Systolic and diastolic blood pressure will be measured in a supine position at pre-dose, Days 2, 3, 4,5,6,7,43 and 85 post-dose
Measurement of pulse rate as a measure of safety Up to 18 weeks Pulse rate will be measured in a supine position at pre-dose, Days 2, 3, 4,5,6,7,43 and 85 post-dose
Trial Locations
- Locations (1)
GSK Investigational Site
🇺🇸Austin, Texas, United States