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

NCT02028598 | Completed Phase 1

• 1 other identifier: CTC-PED-DDI-1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Keywords

Clomipramine; Premature ejaculation

Outcome Measures

Primary Outcomes (2)

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

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

• The maximum concentration (Cmax)

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

Secondary Outcomes (6)

• Pharmacokinetic parameters except the primary endpoints

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

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

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

• Adverse events

  For 3 Weeks after dosing

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

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

• The maximum change of heart rates within 12 hours after dosing

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

Study Arms (6)

Sequence A

EXPERIMENTAL

Treatment 1 - Treatment 2 - Treatment 3

Drug: Treatment 1; Drug: Treatment 2; Drug: Treatment 3

Sequence B

EXPERIMENTAL

Treatment 1 - Treatment 3 - Treatment 2

Drug: Treatment 1; Drug: Treatment 2; Drug: Treatment 3

Sequence C

EXPERIMENTAL

Treatment 2 - Treatment 1 - Treatment 3

Drug: Treatment 1; Drug: Treatment 2; Drug: Treatment 3

Sequence D

EXPERIMENTAL

Treatment 2 - Treatment 3 - Treatment 1

Drug: Treatment 1; Drug: Treatment 2; Drug: Treatment 3

Sequence E

EXPERIMENTAL

Treatment 3 - Treatment 1 - Treatment 2

Drug: Treatment 1; Drug: Treatment 2; Drug: Treatment 3

Sequence F

EXPERIMENTAL

Treatment 3 - Treatment 2 - Treatment 1

Drug: Treatment 1; Drug: Treatment 2; Drug: Treatment 3

Interventions

Treatment 1 DRUG

An oral single dose administration

Also known as: Clomipramine HCl 15mg (Condencia Tab)

Sequence A; Sequence B; Sequence C; Sequence D; Sequence E; Sequence F

Treatment 2 DRUG

An oral single dose administration

Also known as: Sildenafil citrate 100mg (Viagra Tab)

Sequence A; Sequence B; Sequence C; Sequence D; Sequence E; Sequence F

Treatment 3 DRUG

Co-administration of oral single doses

Also known as: Clomipramine HCl 15mg (Condencia Tab), Sildenafil citrate 100mg (Viagra Tab)

Sequence A; Sequence B; Sequence C; Sequence D; Sequence E; Sequence F

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• CTC Bio, Inc.: lead
• Symyoo: collaborator

Study Sites (1)

Yangji Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Premature Ejaculation

Interventions

Clomipramine; Sildenafil Citrate

Condition Hierarchy (Ancestors)

Ejaculatory Dysfunction; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Piperazines; Heterocyclic Compounds, 1-Ring; Purines; Heterocyclic Compounds, 2-Ring

Study Officials

• Yun Hi Kang, M.D.

  Yangji Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2014
• First Posted: January 7, 2014
• Study Start: January 1, 2014
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: September 15, 2014

Record last verified: 2014-09

Locations

KR (1)