Drug-Drug Interaction of Clomipramine HCl and Sildenafil Citrate in Healthy Males
Launched by CTC BIO, INC. · Jan 6, 2014
Trial Information
Current as of June 07, 2025
Completed
Keywords
ClinConnect Summary
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 subje...
Gender
MALE
Eligibility 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
About Ctc Bio, Inc.
ctc bio, inc. is a leading biopharmaceutical company dedicated to advancing innovative therapies through rigorous clinical research and development. With a focus on oncology and other critical therapeutic areas, ctc bio leverages cutting-edge technologies and a robust pipeline to address unmet medical needs. The company is committed to fostering partnerships within the scientific community and adhering to the highest standards of regulatory compliance, ensuring the safety and efficacy of its investigational products. Through its expertise and dedication to patient-centric solutions, ctc bio aims to contribute significantly to the future of healthcare.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Seoul, , Korea, Republic Of
Patients applied
Trial Officials
Yun Hi Kang, M.D.
Principal Investigator
Yangji Hospital
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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