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

September 12, 2014 updated by: CTC Bio, Inc.

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

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Sequence A
Treatment 1 - Treatment 2 - Treatment 3
An oral single dose administration
Other Names:
  • Clomipramine HCl 15mg (Condencia Tab)
An oral single dose administration
Other Names:
  • Sildenafil citrate 100mg (Viagra Tab)
Co-administration of oral single doses
Other Names:
  • Clomipramine HCl 15mg (Condencia Tab)
  • Sildenafil citrate 100mg (Viagra Tab)
EXPERIMENTAL: Sequence B
Treatment 1 - Treatment 3 - Treatment 2
An oral single dose administration
Other Names:
  • Clomipramine HCl 15mg (Condencia Tab)
An oral single dose administration
Other Names:
  • Sildenafil citrate 100mg (Viagra Tab)
Co-administration of oral single doses
Other Names:
  • Clomipramine HCl 15mg (Condencia Tab)
  • Sildenafil citrate 100mg (Viagra Tab)
EXPERIMENTAL: Sequence C
Treatment 2 - Treatment 1 - Treatment 3
An oral single dose administration
Other Names:
  • Clomipramine HCl 15mg (Condencia Tab)
An oral single dose administration
Other Names:
  • Sildenafil citrate 100mg (Viagra Tab)
Co-administration of oral single doses
Other Names:
  • Clomipramine HCl 15mg (Condencia Tab)
  • Sildenafil citrate 100mg (Viagra Tab)
EXPERIMENTAL: Sequence D
Treatment 2 - Treatment 3 - Treatment 1
An oral single dose administration
Other Names:
  • Clomipramine HCl 15mg (Condencia Tab)
An oral single dose administration
Other Names:
  • Sildenafil citrate 100mg (Viagra Tab)
Co-administration of oral single doses
Other Names:
  • Clomipramine HCl 15mg (Condencia Tab)
  • Sildenafil citrate 100mg (Viagra Tab)
EXPERIMENTAL: Sequence E
Treatment 3 - Treatment 1 - Treatment 2
An oral single dose administration
Other Names:
  • Clomipramine HCl 15mg (Condencia Tab)
An oral single dose administration
Other Names:
  • Sildenafil citrate 100mg (Viagra Tab)
Co-administration of oral single doses
Other Names:
  • Clomipramine HCl 15mg (Condencia Tab)
  • Sildenafil citrate 100mg (Viagra Tab)
EXPERIMENTAL: Sequence F
Treatment 3 - Treatment 2 - Treatment 1
An oral single dose administration
Other Names:
  • Clomipramine HCl 15mg (Condencia Tab)
An oral single dose administration
Other Names:
  • Sildenafil citrate 100mg (Viagra Tab)
Co-administration of oral single doses
Other Names:
  • Clomipramine HCl 15mg (Condencia Tab)
  • Sildenafil citrate 100mg (Viagra Tab)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The systemic exposure measured as area under the curve (AUC)
Time Frame: From Day 1(dosing) to Day 4(72hrs)
From Day 1(dosing) to Day 4(72hrs)
The maximum concentration (Cmax)
Time Frame: From Day 1(dosing) to Day 4(72hrs)
From Day 1(dosing) to Day 4(72hrs)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetic parameters except the primary endpoints
Time Frame: From Day 1(dosng) to Day 4(72hrs)
Including Tmax, T1/2, AUCnorm, Cmax norm, CL/f and Cmax/AUC
From Day 1(dosng) to Day 4(72hrs)
The maximum change of systolic blood pressures within 12hrs after dosing
Time Frame: Day 1(dosing) to Day 2(12hrs)
At supine and upright positions
Day 1(dosing) to Day 2(12hrs)
Adverse events
Time Frame: For 3 Weeks after dosing
For 3 Weeks after dosing
The maximum change of dystolic blood pressure within 12hrs after dosing
Time Frame: From Day 1(dosing) to Day 2(12hrs)
at supine and upright positions
From Day 1(dosing) to Day 2(12hrs)
The maximum change of heart rates within 12 hours after dosing
Time Frame: From Day 1(dosing) to Day 2(12hrs)
At supine and upright positions
From Day 1(dosing) to Day 2(12hrs)
The rate of the subjects who experienced the clinically significant change of blood pressures
Time Frame: 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)
From Day 1(dosing) to Days 2(12hrs)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Collaborators

Investigators

  • Principal Investigator: Yun Hi Kang, M.D., Yangji Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (ACTUAL)

March 1, 2014

Study Completion (ACTUAL)

March 1, 2014

Study Registration Dates

First Submitted

January 3, 2014

First Submitted That Met QC Criteria

January 6, 2014

First Posted (ESTIMATE)

January 7, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

September 15, 2014

Last Update Submitted That Met QC Criteria

September 12, 2014

Last Verified

September 1, 2014

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Healthy

Clinical Trials on Treatment 1

3
Subscribe