Healthy
Conditions
Keywords
Clomipramine, Premature ejaculation
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.
Interventions
DRUGTreatment 1
An oral single dose administration
DRUGTreatment 2
An oral single dose administration
DRUGTreatment 3
Co-administration of oral single doses
Sponsors
Symyoo
CTC Bio, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
19 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The systemic exposure measured as area under the curve (AUC) | From Day 1(dosing) to Day 4(72hrs) |
| The maximum concentration (Cmax) | From Day 1(dosing) to Day 4(72hrs) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | at supine and upright positions |
| Pharmacokinetic parameters except the primary endpoints | From Day 1(dosng) to Day 4(72hrs) | Including Tmax, T1/2, AUCnorm, Cmax norm, CL/f and Cmax/AUC |
| The rate of the subjects who experienced the clinically significant change of blood pressures | From Day 1(dosing) to Days 2(12hrs) | Clinically significant changes will be classified into 4 groups: SBP change \>=30 or 20 mmHg, DBP change \>= 20 or 10 mmHg (at supine and upright positions) |
| The maximum change of heart rates within 12 hours after dosing | From Day 1(dosing) to Day 2(12hrs) | At supine and upright positions |
| The maximum change of systolic blood pressures within 12hrs after dosing | Day 1(dosing) to Day 2(12hrs) | At supine and upright positions |
Countries
South Korea
Outcome results
None listed