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

Phase 1CompletedNCT02028598

CTC Bio, Inc.30 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

Treatment 1DRUG

An oral single dose administration

Treatment 2DRUG

An oral single dose administration

Treatment 3DRUG

Co-administration of oral single doses

Eligibility

Sex: MALEMin age: 19 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Yangji Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

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)

Secondary Outcomes

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)

Data from ClinicalTrials.gov

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