- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02028598
Drug-Drug Interaction of Clomipramine HCl and Sildenafil Citrate in Healthy Males
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 Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
-
Seoul, Korea, Republic of
- Yangji Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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:
An oral single dose administration
Other Names:
Co-administration of oral single doses
Other Names:
|
EXPERIMENTAL: Sequence B
Treatment 1 - Treatment 3 - Treatment 2
|
An oral single dose administration
Other Names:
An oral single dose administration
Other Names:
Co-administration of oral single doses
Other Names:
|
EXPERIMENTAL: Sequence C
Treatment 2 - Treatment 1 - Treatment 3
|
An oral single dose administration
Other Names:
An oral single dose administration
Other Names:
Co-administration of oral single doses
Other Names:
|
EXPERIMENTAL: Sequence D
Treatment 2 - Treatment 3 - Treatment 1
|
An oral single dose administration
Other Names:
An oral single dose administration
Other Names:
Co-administration of oral single doses
Other Names:
|
EXPERIMENTAL: Sequence E
Treatment 3 - Treatment 1 - Treatment 2
|
An oral single dose administration
Other Names:
An oral single dose administration
Other Names:
Co-administration of oral single doses
Other Names:
|
EXPERIMENTAL: Sequence F
Treatment 3 - Treatment 2 - Treatment 1
|
An oral single dose administration
Other Names:
An oral single dose administration
Other Names:
Co-administration of oral single doses
Other Names:
|
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
Sponsor
Collaborators
Investigators
- Principal Investigator: Yun Hi Kang, M.D., Yangji Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Vasodilator Agents
- Urological Agents
- Enzyme Inhibitors
- Psychotropic Drugs
- Serotonin Uptake Inhibitors
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Serotonin Agents
- Antidepressive Agents
- Antidepressive Agents, Tricyclic
- Anticoagulants
- Phosphodiesterase Inhibitors
- Chelating Agents
- Sequestering Agents
- Phosphodiesterase 5 Inhibitors
- Calcium Chelating Agents
- Clomipramine
- Sildenafil Citrate
- Citric Acid
- Sodium Citrate
Other Study ID Numbers
- CTC-PED-DDI-1
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
-
Prevent Age Resort "Pervaya Liniya"RecruitingHealthy Aging | Healthy Diet | Healthy LifestyleRussian Federation
-
Maastricht University Medical CenterCompletedHealthy Volunteers | Healthy Subjects | Healthy AdultsNetherlands
-
Yale UniversityNot yet recruitingHealth-related Benefits of Introducing Table Olives Into the Diet of Young Adults: Olives For HealthHealthy Diet | Healthy Lifestyle | Healthy Nutrition | CholesterolUnited States
-
University of PennsylvaniaActive, not recruitingHealthy | Healthy AgingUnited States
-
Chalmers University of TechnologyGöteborg UniversityCompletedHealthy | Nutrition, HealthySweden
-
Hasselt UniversityRecruitingHealthy | Healthy AgingBelgium
-
Galera Therapeutics, Inc.Syneos HealthCompleted
-
Galera Therapeutics, Inc.Syneos HealthCompletedHealthy | Healthy VolunteersAustralia
-
University of ManitobaNot yet recruitingHealthy | Healthy Diet
-
King's College LondonUniversity of ReadingCompletedHealthy | Healthy AgingUnited Kingdom
Clinical Trials on Treatment 1
-
PfizerCompletedRheumatoid Arthritis | Healthy VolunteersUnited States
-
Genentech, Inc.Completed
-
AstraZenecaAcerta Pharma, LLCCompletedBioavailability | B-cell Lymphoid CancerUnited States
-
University of Erlangen-NürnbergFa. Reck MOTOmedCompleted
-
Duke UniversityStanford University; Department for International Development, United Kingdom; International Initiative for Impact Evaluation and other collaboratorsCompletedSepsis | Obstetric Labor Complications | Pre-eclampsia | Neonatal Mortality | Post-partum HemorrhageIndia
-
Changhai HospitalNot yet recruitingBreast Neoplasms | Metastatic Breast Cancer | Treatment | Survival
-
Northwestern UniversityNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); University...Completed
-
AVAVA, Inc.Completed
-
Nihon Pharmaceutical Co., LtdCompleted