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Trial record 4 of 4 for:    "Premature Ejaculation" | "Antidepressive Agents, Tricyclic"

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

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ClinicalTrials.gov Identifier: NCT02028598
Recruitment Status : Completed
First Posted : January 7, 2014
Last Update Posted : September 15, 2014
Sponsor:
Collaborator:
Symyoo
Information provided by (Responsible Party):
CTC Bio, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Treatment 1 Drug: Treatment 2 Drug: Treatment 3 Phase 1

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Study Start Date : January 2014
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Sequence A
Treatment 1 - Treatment 2 - Treatment 3
Drug: Treatment 1
An oral single dose administration
Other Name: Clomipramine HCl 15mg (Condencia Tab)

Drug: Treatment 2
An oral single dose administration
Other Name: 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)

Experimental: Sequence B
Treatment 1 - Treatment 3 - Treatment 2
Drug: Treatment 1
An oral single dose administration
Other Name: Clomipramine HCl 15mg (Condencia Tab)

Drug: Treatment 2
An oral single dose administration
Other Name: 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)

Experimental: Sequence C
Treatment 2 - Treatment 1 - Treatment 3
Drug: Treatment 1
An oral single dose administration
Other Name: Clomipramine HCl 15mg (Condencia Tab)

Drug: Treatment 2
An oral single dose administration
Other Name: 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)

Experimental: Sequence D
Treatment 2 - Treatment 3 - Treatment 1
Drug: Treatment 1
An oral single dose administration
Other Name: Clomipramine HCl 15mg (Condencia Tab)

Drug: Treatment 2
An oral single dose administration
Other Name: 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)

Experimental: Sequence E
Treatment 3 - Treatment 1 - Treatment 2
Drug: Treatment 1
An oral single dose administration
Other Name: Clomipramine HCl 15mg (Condencia Tab)

Drug: Treatment 2
An oral single dose administration
Other Name: 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)

Experimental: Sequence F
Treatment 3 - Treatment 2 - Treatment 1
Drug: Treatment 1
An oral single dose administration
Other Name: Clomipramine HCl 15mg (Condencia Tab)

Drug: Treatment 2
An oral single dose administration
Other Name: 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)




Primary Outcome Measures :
  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 Outcome Measures :
  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)



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Ages Eligible for Study:   19 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02028598


Locations
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Korea, Republic of
Yangji Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
CTC Bio, Inc.
Symyoo
Investigators
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Principal Investigator: Yun Hi Kang, M.D. Yangji Hospital

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Responsible Party: CTC Bio, Inc.
ClinicalTrials.gov Identifier: NCT02028598     History of Changes
Other Study ID Numbers: CTC-PED-DDI-1
First Posted: January 7, 2014    Key Record Dates
Last Update Posted: September 15, 2014
Last Verified: September 2014
Keywords provided by CTC Bio, Inc.:
Clomipramine
Premature ejaculation
Additional relevant MeSH terms:
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Antidepressive Agents, Tricyclic
Sildenafil Citrate
Clomipramine
Citric Acid
Sodium Citrate
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Urological Agents
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs