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

CTCBIO

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Treatment 3; Drug: Treatment 1; Drug: Treatment 2

Study type: Interventional

Funder types: Industry

Identifiers

NCT02028598

CTC-PED-DDI-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: Male

Ages: 19 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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30 participants in 6 patient groups

Sequence A

Experimental group

Description:

Treatment 1 - Treatment 2 - Treatment 3

Treatment:

Drug: Treatment 2

Drug: Treatment 1

Drug: Treatment 3

Sequence B

Experimental group

Description:

Treatment 1 - Treatment 3 - Treatment 2

Treatment:

Drug: Treatment 2

Drug: Treatment 1

Drug: Treatment 3

Sequence C

Experimental group

Description:

Treatment 2 - Treatment 1 - Treatment 3

Treatment:

Drug: Treatment 2

Drug: Treatment 1

Drug: Treatment 3

Sequence D

Experimental group

Description:

Treatment 2 - Treatment 3 - Treatment 1

Treatment:

Drug: Treatment 2

Drug: Treatment 1

Drug: Treatment 3

Sequence E

Experimental group

Description:

Treatment 3 - Treatment 1 - Treatment 2

Treatment:

Drug: Treatment 2

Drug: Treatment 1

Drug: Treatment 3

Sequence F

Experimental group

Description:

Treatment 3 - Treatment 2 - Treatment 1

Treatment:

Drug: Treatment 2

Drug: Treatment 1

Drug: Treatment 3