An Open-Label, Randomized, Single Dose Crossover Study to Determine the Bioequivalence of Duodart® 0.5mg/0.4mg (Capsule Formulation of Dutasteride 0.5mg and Tamsulosin Hydrochloride 0.4mg) Compared to Concomitant Dosing of Avodart® 0.5mg and Omnic® 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
- 35
- 试验地点
- 1
- 主要终点
- bioequivalence of a Combination Capsule formulation of dutasteride 0.5 mg/ tamsulosin HCl 0.4 mg (Duodart® 0.5 mg/ 0.4 mg fixed combination) relative to concomitant dosing of Avodart® 0.5 mg and the Omnic® 0.4
研究概览
简要总结
Open-label, randomized, single dose, two-treatment, two-way crossover study
详细描述
The present study is planned to establish bioequivalence of Duodart® 0.5mg/0.4mg manufactured by GlaxoSmithKline to concomitant dosing with separate capsules of dutasteride 0.5 mg and tamsulosin hydrochloride 0.4 mg formulations commercially available in Russia. The design of the present study relies on data obtained in pivotal bioequivalence study and Russian guidance on high quality bioequivalence studies.
Summary of treatment groups Treatment Sequence Number of subjects
- 18
- 18 Total number of subjects 36 Eligible subjects will be admitted to the research unit one day prior to dosing (Day 0) and will remain as inpatients until approximately 72 hours after dosing. Subjects will undergo a washout period of approximately 28 days from each dose of study medication. During washout period subjects will be contacted via telephone within approximately 10-14 days after the dosing for the collection of information about adverse events and medications taken by volunteers during washout period Overall study duration could be about 2 months - Screening up to 21 days + 10 days (5 days of each of 2 treatment periods) + 28 days washout period between treatment administration + 10-14 days of follow up period.
Upon completion of the last dosing session, subjects will be contacted via telephone within approximately 10-14 days for a follow-up inquiry (or visit at the discretion of the investigator) and will be subsequently discharged from the study.
- Order of Assessments and Procedures
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
- •Willing and able to give written informed consent
- •Males who are 18 - 45 years of age, inclusive
- •Verified diagnosis "healthy"
- •Body mass index 20-25 kg/m2 (inclusive)
- •Negative results of test for HIV, syphilis, hepatitis B (HBs Ag) and hepatitis C
- •Adequate, liver, and renal function
- •adequate contraception
排除标准
- •Poor metabolizer for CYP2D6
- •Medical history of allergy
- •Medical history of medicines intolerability
- •Chronic diseases
- •History of surgery on gastrointestinal tract
- •History of prostate cancer
- •History of breast cancer
- •Acute infectious disease
- •Regular use of drugs
- •Intake of medicines with high influence on liver function or haemodynamics
- •Use of drugs that influence activity of CYP2D6 and CYP3A4
- •Use of Dutasteride less than 6 months before study entry or alpha-blockers less than 2 weeks before study entry
- •Blood donation (≥450 mL of blood or plasma) less than 2 months before study start
- •History of regular alcohol consumption
- •A positive urine drug or alcohol
- •Smoking more than 10 cigarettes a day
- •Participation in Phase I clinical trials less than 3 months before study entry
- •History of postural hypotension, dizziness, poor hydration, vertigo, vaso-vagal reactions or any other signs and symptoms of orthostasis
- •Subjects who have consumed the following foods or drinks within 7 days prior to the first dose of study medication or at any time during the clinical phase of the study: grapefruit juice; red wine; grapefruit or cruciferous vegetables (watercress, broccoli, cabbage, Brussels sprouts).
- •QTc ≥ 450 msec at screening
研究组 & 干预措施
dutasteride/tamsulosin
The present study is planned to establish bioequivalence of Duodart® 0.5mg/0.4mg manufactured by GlaxoSmithKline to concomitant dosing with separate capsules of dutasteride 0.5 mg and tamsulosin hydrochloride 0.4 mg formulations commercially available in Russia.
干预措施: dutasteride/tamsulosin (Drug)
dutasteride
Dutasteride (Avodart®) is an approved potent dual type I and II, 5-alpha-reductase inhibitor indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to improve symptoms, reduce the risk of acute urinary retention and reduce the risk of the need for BPH-related surgery.
干预措施: dutasteride (Drug)
dutasteride
Dutasteride (Avodart®) is an approved potent dual type I and II, 5-alpha-reductase inhibitor indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to improve symptoms, reduce the risk of acute urinary retention and reduce the risk of the need for BPH-related surgery.
干预措施: tamsulosin (Drug)
tamsulosin
Tamsulosin (Omnic®) is an alpha-1A-adrenocepter blocking agent approved for the treatment of signs and symptoms of benign prostatic hyperplasia
干预措施: dutasteride (Drug)
tamsulosin
Tamsulosin (Omnic®) is an alpha-1A-adrenocepter blocking agent approved for the treatment of signs and symptoms of benign prostatic hyperplasia
干预措施: tamsulosin (Drug)
结局指标
主要结局
bioequivalence of a Combination Capsule formulation of dutasteride 0.5 mg/ tamsulosin HCl 0.4 mg (Duodart® 0.5 mg/ 0.4 mg fixed combination) relative to concomitant dosing of Avodart® 0.5 mg and the Omnic® 0.4
时间窗: 2 months
Dutasteride and tamsulosin will be extracted from human plasma by liquid-liquid extraction using organic solvent. Extracts will be analysed by validated high-performance liquid chromatography - mass spectrometry. The lower limit of detection is about 0.1ng/mL
次要结局
- to evaluate the safety and tolerability of the Combination Capsule formulation of dutasteride 0.5 mg/ tamsulosin HCl 0.4 mg(2 months)