CompletedPhase 1

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

South Korea30 participantsStarted 2014-01

Plain-language 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.

Who can participate

Age range

19 Years – 65 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: From Day 1(dosing) to Day 4(72hrs)

The maximum concentration (Cmax)

Timeframe: From Day 1(dosing) to Day 4(72hrs)

Trial details

NCT IDNCT02028598

SponsorCTC Bio, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2014-03

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