Evaluation of Metabolic Markers for the Prediction of DDI of Various CYP3A Substrates and Inhibitors

• Status: Unknown status
• Trial end date: 2017-04-01
• Target enrollment: 0
• Participant gender: Male

Summary

Evaluation and validation of metabolic markers for the prediction of drug-drug interaction of various CYP3A4 substrates (sildenafil) and inhibitors (erythromycin/itraconazole) in healthy male subjects

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Seoul National University Hospital
• Treatments: Erythromycin; Erythromycin Estolate; Erythromycin Ethylsuccinate; Erythromycin stearate; Hydroxyitraconazole; Itraconazole; Sildenafil Citrate

Criteria

Inclusion Criteria:

• Age: Between 19 to 50 years of age, inclusive

• Weight: within 17-28 of Body Mass Index (BMI)

• Subject who are reliable and willing to make themselves available during the study period.

• Subject who are willing to follow the study protocol, and give their written informed consent voluntarily.

Exclusion Criteria:

• History of hypersensitive reaction to medication (midazolam, itraconazole, rifampicin)

• History of significant clinical illness needs medical caution, including cardiovascular, immunologic, hematologic, neuropsychiatric, respiratory, gastrointestinal, hepatic, or renal disease or other chronic disease

• History or evidence of drug abuse

• Use any prescriptive medication, Korean traditional medication not considered acceptable by the clinical investigator during the last 14 days period before first dosing, or use any medication not considered acceptable by the clinical investigator during the last 7 days period before first dosing (if used medication is considered acceptable by investigator, patients can be included)

• Participation in clinical trials of any drug within 3 months prior to the participation of the study

• Judged to be inappropriate for the study by the investigator