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Completed

NCT Number: NCT02028598

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

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.

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Key information

Conditions

Healthy Ejaculatory Dysfunction Genital Diseases Genital Diseases, Male Male Urogenital Diseases Mental Disorders Premature Ejaculation Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Urogenital Diseases

Age range

19 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Yangji Hospital

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Treatment 1

Drug

An oral single dose administration

Other names: Clomipramine HCl 15mg (Condencia Tab)

Treatment 2

Drug

An oral single dose administration

Other names: Sildenafil citrate 100mg (Viagra Tab)

Treatment 3

Drug

Co-administration of oral single doses

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

Primary outcomes

  1. The systemic exposure measured as area under the curve (AUC)

    Time frame: From Day 1(dosing) to Day 4(72hrs)

  2. The maximum concentration (Cmax)

    Time frame: From Day 1(dosing) to Day 4(72hrs)

Secondary outcomes

  1. 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

  2. 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

  3. Adverse events

    Time frame: For 3 Weeks after dosing

  4. 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

  5. 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

  6. 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)

Sponsors and collaborators

Lead sponsor

CTC Bio, Inc.

Industry

Collaborators

  • Symyoo

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jan 7, 2014
Registry last updated
Sep 15, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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