A Randomized, Open-labeled, 6-sequence, 3-period, 3-treatment Crossover Study to Evaluate the Effect of Co-administration of Clomipramine HCl (Condencia Tab.) 15mg and Sildenafil Citrate (Viagra Tab.) 100mg on the Safety and Pharmacokinetic/Pharmacodynamic Properties of Clomipramine and Sildenafil Compared to the Effects After Single Oral Administration in Healthy Male Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- The maximum concentration (Cmax)
研究概览
简要总结
The purpose of this study is to evaluate the safety and pharmacokinetics/pharmacodynamics of co-administration of Clomipramine HCl 15mg and Sildenafil citrate 100mg compared to the effects after single oral administration in Korean healthy male volunteers.
详细描述
Clomipramine is a dibenzazepine-derivative tricyclic antidepressant (TCA) and is a potent inhibitor of serotonin and norepinephrine reuptake. Clomipramine may be used in a variety of indications. Condencia Tab contains low dose of 15mg of clomipramine HCl as an active ingredient, which is newly approved to market for the treatment of premature ejaculation.
This study is a prospective, randomised, open-labeled, 6-sequence, 3-period, 3-treatment, crossover, and single-center clinical trial. A total of 30 healthy male volunteers will be enrolled and randomised into one among 6 groups (5 subjects per a group). The safety and PK/PD characteristics of co-administration of Clomipramine HCl and Sildenafil citrate will be investigated closely compared to the effects after single dose administrations.
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
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Korean healthy males aged between 19 and 65
- •Body weight between 60kg and 90kg, BMI between 19 and 27
- •Given informed consent
排除标准
- •Clinically significant medical history and/or concurrent disease
- •SBP >=140 mmHg or <=90 mmHg, DBP >=95 mmHg or <=50 mmHg
- •Orthostatic hypotension
- •Hypersensitivity to any ingredient of investigational drugs
- •Severe bleeding or blood donation within 8 weeks prior to study participation
- •Alcoholism or drug abuser
- •Smoking more than 0.5 pack-year
- •Persistent alcohol consumption more than 21 units(210g)/week
- •Participation in other investigational clinical trial
研究组 & 干预措施
Sequence A
Treatment 1 - Treatment 2 - Treatment 3
干预措施: Treatment 1 (Drug)
Sequence A
Treatment 1 - Treatment 2 - Treatment 3
干预措施: Treatment 2 (Drug)
Sequence A
Treatment 1 - Treatment 2 - Treatment 3
干预措施: Treatment 3 (Drug)
Sequence B
Treatment 1 - Treatment 3 - Treatment 2
干预措施: Treatment 1 (Drug)
Sequence B
Treatment 1 - Treatment 3 - Treatment 2
干预措施: Treatment 2 (Drug)
Sequence B
Treatment 1 - Treatment 3 - Treatment 2
干预措施: Treatment 3 (Drug)
Sequence C
Treatment 2 - Treatment 1 - Treatment 3
干预措施: Treatment 1 (Drug)
Sequence C
Treatment 2 - Treatment 1 - Treatment 3
干预措施: Treatment 2 (Drug)
Sequence C
Treatment 2 - Treatment 1 - Treatment 3
干预措施: Treatment 3 (Drug)
Sequence D
Treatment 2 - Treatment 3 - Treatment 1
干预措施: Treatment 1 (Drug)
Sequence D
Treatment 2 - Treatment 3 - Treatment 1
干预措施: Treatment 2 (Drug)
Sequence D
Treatment 2 - Treatment 3 - Treatment 1
干预措施: Treatment 3 (Drug)
Sequence E
Treatment 3 - Treatment 1 - Treatment 2
干预措施: Treatment 1 (Drug)
Sequence E
Treatment 3 - Treatment 1 - Treatment 2
干预措施: Treatment 2 (Drug)
Sequence E
Treatment 3 - Treatment 1 - Treatment 2
干预措施: Treatment 3 (Drug)
Sequence F
Treatment 3 - Treatment 2 - Treatment 1
干预措施: Treatment 1 (Drug)
Sequence F
Treatment 3 - Treatment 2 - Treatment 1
干预措施: Treatment 2 (Drug)
Sequence F
Treatment 3 - Treatment 2 - Treatment 1
干预措施: Treatment 3 (Drug)
结局指标
主要结局
The maximum concentration (Cmax)
时间窗: From Day 1(dosing) to Day 4(72hrs)
The systemic exposure measured as area under the curve (AUC)
时间窗: From Day 1(dosing) to Day 4(72hrs)
次要结局
- Pharmacokinetic parameters except the primary endpoints(From Day 1(dosng) to Day 4(72hrs))
- The maximum change of systolic blood pressures within 12hrs after dosing(Day 1(dosing) to Day 2(12hrs))
- Adverse events(For 3 Weeks after dosing)
- The maximum change of dystolic blood pressure within 12hrs after dosing(From Day 1(dosing) to Day 2(12hrs))
- The maximum change of heart rates within 12 hours after dosing(From Day 1(dosing) to Day 2(12hrs))
- The rate of the subjects who experienced the clinically significant change of blood pressures(From Day 1(dosing) to Days 2(12hrs))