Clinical trial NCT02028598: Drug-Drug Interaction of Clomipramine HCl and Sildenafil Citrate in Healthy Males
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Clomipramine
Premature ejaculation
Lead sponsor: CTC Bio, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Symyoo
First posted: 2014-01-07
Enrollment: 30
Sex: MALE
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Korean healthy males aged between 19 and 65
* Body weight between 60kg and 90kg, BMI between 19 and 27
* Given informed consent

Exclusion Criteria:

* 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

Primary outcomes:
measure: The systemic exposure measured as area under the curve (AUC)
timeFrame: From Day 1(dosing) to Day 4(72hrs)
measure: The maximum concentration (Cmax)
timeFrame: From Day 1(dosing) to Day 4(72hrs)
Secondary outcomes:
measure: Pharmacokinetic parameters except the primary endpoints
timeFrame: From Day 1(dosng) to Day 4(72hrs)
measure: The maximum change of systolic blood pressures within 12hrs after dosing
timeFrame: Day 1(dosing) to Day 2(12hrs)
measure: Adverse events
timeFrame: For 3 Weeks after dosing
measure: The maximum change of dystolic blood pressure within 12hrs after dosing
timeFrame: From Day 1(dosing) to Day 2(12hrs)
measure: The maximum change of heart rates within 12 hours after dosing
timeFrame: From Day 1(dosing) to Day 2(12hrs)
measure: The rate of the subjects who experienced the clinically significant change of blood pressures
timeFrame: From Day 1(dosing) to Days 2(12hrs)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yangji Hospital
Study officials:
affiliation: Yangji Hospital
name: Yun Hi Kang, M.D.
role: PRINCIPAL_INVESTIGATOR
References: