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

Information source: CTC Bio, Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: Treatment 1 (Drug); Treatment 2 (Drug); Treatment 3 (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: CTC Bio, Inc.

Official(s) and/or principal investigator(s):
Yun Hi Kang, M.D., Principal Investigator, Affiliation: Yangji Hospital

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

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

The maximum concentration (Cmax)

Secondary outcome:

Pharmacokinetic parameters except the primary endpoints

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

Adverse events

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

The maximum change of heart rates within 12 hours after dosing

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

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.

Eligibility

Minimum age: 19 Years. Maximum age: 65 Years. Gender(s): Male.

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

Locations and Contacts

Yangji Hospital, Seoul, Korea, Republic of
Additional Information

Starting date: January 2014
Last updated: September 12, 2014

Page last updated: August 23, 2015

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