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HealthyPhase 1NCT02028598

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

A Phase 1 study testing Treatment 1, Treatment 2 and Treatment 3 in people with Healthy, run by CTC Bio, Inc. at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 19 to 65 years, men onlyHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Treatment 1, Treatment 2 and Treatment 3
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteSouth Korea
Study dates
Jan 2014to Mar 2014
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 65 years
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Korean healthy males aged between 19 and 65
  • Body weight between 60kg and 90kg, BMI between 19 and 27
  • Given informed consent

Who cannot join

  • 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
Show all 9Show fewer
  • Smoking more than 0.5 pack-year
  • Persistent alcohol consumption more than 21 units(210g)/week
  • Participation in other investigational clinical trial

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Yangji Hospital

    Seoul

Other trials in South Korea

About this study

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

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.

Read the 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.

Conditions
Healthy
Being tested
Treatment 1, Treatment 2, Treatment 3
Keywords
Clomipramine, Premature ejaculation
Medical subject headings
Premature Ejaculation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Treatment 1Drug

    Also called Clomipramine HCl 15mg (Condencia Tab)

    An oral single dose administration

  • Treatment 2Drug

    Also called Sildenafil citrate 100mg (Viagra Tab)

    An oral single dose administration

  • Treatment 3Drug

    Also called Clomipramine HCl 15mg (Condencia Tab), Sildenafil citrate 100mg (Viagra Tab)

    Co-administration of oral single doses

Study groups in NCT02028598
Study groupRoleWhat they receive
Sequence AExperimentalTreatment 1 - Treatment 2 - Treatment 3
Receives: Drug: Treatment 1; Drug: Treatment 2; Drug: Treatment 3
Sequence BExperimentalTreatment 1 - Treatment 3 - Treatment 2
Receives: Drug: Treatment 1; Drug: Treatment 2; Drug: Treatment 3
Sequence CExperimentalTreatment 2 - Treatment 1 - Treatment 3
Receives: Drug: Treatment 1; Drug: Treatment 2; Drug: Treatment 3
Sequence DExperimentalTreatment 2 - Treatment 3 - Treatment 1
Receives: Drug: Treatment 1; Drug: Treatment 2; Drug: Treatment 3
Sequence EExperimentalTreatment 3 - Treatment 1 - Treatment 2
Receives: Drug: Treatment 1; Drug: Treatment 2; Drug: Treatment 3
Sequence FExperimentalTreatment 3 - Treatment 2 - Treatment 1
Receives: Drug: Treatment 1; Drug: Treatment 2; Drug: Treatment 3

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

  2. The maximum concentration (Cmax)

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

Secondary outcomes (6)

  1. Pharmacokinetic parameters except the primary endpoints

    Including Tmax, T1/2, AUCnorm, Cmax norm, CL/f and Cmax/AUC

    Measured: From Day 1(dosng) to Day 4(72hrs)

  2. The maximum change of systolic blood pressures within 12hrs after dosing

    At supine and upright positions

    Measured: Day 1(dosing) to Day 2(12hrs)

  3. Adverse events

    Measured: For 3 Weeks after dosing

  4. The maximum change of dystolic blood pressure within 12hrs after dosing

    at supine and upright positions

    Measured: From Day 1(dosing) to Day 2(12hrs)

  5. The maximum change of heart rates within 12 hours after dosing

    At supine and upright positions

    Measured: From Day 1(dosing) to Day 2(12hrs)

  6. The rate of the subjects who experienced the clinically significant change of blood pressures

    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)

    Measured: From Day 1(dosing) to Days 2(12hrs)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jan 2014 (estimated)
  2. Study startJan 2014
  3. Primary completionMar 2014
  4. Study completionMar 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02028598
Sponsor's protocol ID
CTC-PED-DDI-1
Status last verified
Sep 2014
First submitted
3 Jan 2014
Last updated
15 Sep 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Treatment 1, Treatment 2 and Treatment 3 in people with Healthy, run by CTC Bio, Inc. at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The systemic exposure measured as area under the curve (AUC) (time frame: From Day 1(dosing) to Day 4(72hrs)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02028598.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2014.

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