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

• Status: Completed
• Trial end date: 2014-03-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: CTC Bio, Inc.
• Collaborator: Symyoo
• Treatments: Citric Acid; Clomipramine; Sildenafil Citrate; Sodium Citrate

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