Trial | NCT02028598  Report issue

Title

Drug-Drug Interaction of Clomipramine HCl and Sildenafil Citrate in Healthy Males
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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    meloxicam ...

  • Study Participants

    30
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.
Study Started
Jan 31
2014
Primary Completion
Mar 31
2014
Study Completion
Mar 31
2014
Last Update
Sep 15
2014
Estimate

Drug Treatment 1

An oral single dose administration

  • Other names: Clomipramine HCl 15mg (Condencia Tab)

Drug Treatment 2

An oral single dose administration

  • Other names: Sildenafil citrate 100mg (Viagra Tab)

Drug Treatment 3

Co-administration of oral single doses

  • Other names: Clomipramine HCl 15mg (Condencia Tab), Sildenafil citrate 100mg (Viagra Tab)

Sequence A Experimental

Treatment 1 - Treatment 2 - Treatment 3

Sequence B Experimental

Treatment 1 - Treatment 3 - Treatment 2

Sequence C Experimental

Treatment 2 - Treatment 1 - Treatment 3

Sequence D Experimental

Treatment 2 - Treatment 3 - Treatment 1

Sequence E Experimental

Treatment 3 - Treatment 1 - Treatment 2

Sequence F Experimental

Treatment 3 - Treatment 2 - Treatment 1

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
No Results Posted