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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- Area under the curve (AUC) from time zero to 24 hours (AUC[0-24]) of plasma tamsulosin in fed state
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Fasted state
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
干预措施: Treatment sequence C (Drug)
Fasted state
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
干预措施: Treatment sequence D (Drug)
Fed state
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
干预措施: Treatment sequence A (Drug)
Fed state
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
干预措施: Treatment sequence B (Drug)
结局指标
主要结局
Area under the curve (AUC) from time zero to 24 hours (AUC[0-24]) of plasma tamsulosin in fed state
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
次要结局
- 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)
- 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)
- 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)
- Number of subjects with adverse event (AE) and serious adverse event (SAE).(Up to 18 weeks)
- Number of subjects with abnormal clinical laboratory parameters(Up to 18 weeks)
- Number of subjects with abnormal hematology laboratory parameters(Up to 18 weeks)
- 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)
- Number of subjects with abnormal urinalysis(Up to 18 weeks)
- Blood pressure assessment as a measure of safety(Up to 18 weeks)
- Measurement of pulse rate as a measure of safety(Up to 18 weeks)