Drug-Drug Interaction of Clomipramine HCl and Sildenafil Citrate in Healthy Males
NCT ID: NCT02028598
Last Updated: 2014-09-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
30 participants
INTERVENTIONAL
2014-01-31
2014-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Sequence A
Treatment 1 - Treatment 2 - Treatment 3
Treatment 1
An oral single dose administration
Treatment 2
An oral single dose administration
Treatment 3
Co-administration of oral single doses
Sequence B
Treatment 1 - Treatment 3 - Treatment 2
Treatment 1
An oral single dose administration
Treatment 2
An oral single dose administration
Treatment 3
Co-administration of oral single doses
Sequence C
Treatment 2 - Treatment 1 - Treatment 3
Treatment 1
An oral single dose administration
Treatment 2
An oral single dose administration
Treatment 3
Co-administration of oral single doses
Sequence D
Treatment 2 - Treatment 3 - Treatment 1
Treatment 1
An oral single dose administration
Treatment 2
An oral single dose administration
Treatment 3
Co-administration of oral single doses
Sequence E
Treatment 3 - Treatment 1 - Treatment 2
Treatment 1
An oral single dose administration
Treatment 2
An oral single dose administration
Treatment 3
Co-administration of oral single doses
Sequence F
Treatment 3 - Treatment 2 - Treatment 1
Treatment 1
An oral single dose administration
Treatment 2
An oral single dose administration
Treatment 3
Co-administration of oral single doses
Interventions
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Treatment 1
An oral single dose administration
Treatment 2
An oral single dose administration
Treatment 3
Co-administration of oral single doses
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Body weight between 60kg and 90kg, BMI between 19 and 27
* Given informed consent
Exclusion Criteria
* 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
19 Years
65 Years
MALE
Yes
Sponsors
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Symyoo
INDUSTRY
CTC Bio, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Yun Hi Kang, M.D.
Role: PRINCIPAL_INVESTIGATOR
Yangji Hospital
Locations
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Yangji Hospital
Seoul, , South Korea
Countries
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Other Identifiers
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CTC-PED-DDI-1
Identifier Type: -
Identifier Source: org_study_id
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