A Phase 1 interventional study of Treatment 1 and Treatment 2 in Healthy, sponsored by CTC Bio, Inc.. Completed at 1 site in Korea, Republic of. Open to male participants aged 19 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-09-15.
Sponsored by CTC Bio, Inc. · Phase 1, Interventional, and Treatment
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.
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.
CTC Bio, Inc. is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Treatment 1 - Treatment 2 - Treatment 3
Drug: Treatment 1 · Drug: Treatment 2 · Drug: Treatment 3
Treatment 1 - Treatment 3 - Treatment 2
Drug: Treatment 1 · Drug: Treatment 2 · Drug: Treatment 3
Treatment 2 - Treatment 1 - Treatment 3
Drug: Treatment 1 · Drug: Treatment 2 · Drug: Treatment 3
Treatment 2 - Treatment 3 - Treatment 1
Drug: Treatment 1 · Drug: Treatment 2 · Drug: Treatment 3
Treatment 3 - Treatment 1 - Treatment 2
Drug: Treatment 1 · Drug: Treatment 2 · Drug: Treatment 3
Treatment 3 - Treatment 2 - Treatment 1
Drug: Treatment 1 · Drug: Treatment 2 · Drug: Treatment 3
An oral single dose administration
Also known as: Clomipramine HCl 15mg (Condencia Tab)
An oral single dose administration
Also known as: Sildenafil citrate 100mg (Viagra Tab)
Co-administration of oral single doses
Also known as: Clomipramine HCl 15mg (Condencia Tab), Sildenafil citrate 100mg (Viagra Tab)
The systemic exposure measured as area under the curve (AUC)
Time frame: From Day 1(dosing) to Day 4(72hrs)
The maximum concentration (Cmax)
Time frame: From Day 1(dosing) to Day 4(72hrs)
Pharmacokinetic parameters except the primary endpoints
Including Tmax, T1/2, AUCnorm, Cmax norm, CL/f and Cmax/AUC
Time frame: From Day 1(dosng) to Day 4(72hrs)
The maximum change of systolic blood pressures within 12hrs after dosing
At supine and upright positions
Time frame: Day 1(dosing) to Day 2(12hrs)
Adverse events
Time frame: For 3 Weeks after dosing
The maximum change of dystolic blood pressure within 12hrs after dosing
at supine and upright positions
Time frame: From Day 1(dosing) to Day 2(12hrs)
The maximum change of heart rates within 12 hours after dosing
At supine and upright positions
Time frame: From Day 1(dosing) to Day 2(12hrs)
The rate of the subjects who experienced the clinically significant change of blood pressures
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)
Time frame: From Day 1(dosing) to Days 2(12hrs)
This study is completed, as verified in Sep 2014. You cannot join it, but the record below documents what was studied.
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CTC Bio, Inc.