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The study objective is to evaluate and validate of endogenous markers for the assessment of CYP3A activity in Korean healthy subjects using metabolomics.
In part 1, total 75 healthy subjects (males and females) will be enrolled. In part 2, total 25 healthy female subject aged 20-45 years will be enrolled. In both part A and B, subjects will be administered midazolam I.V. 1 mg.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Male young adults | Experimental | Arm 1: Male healthy volunteers aged from 20 to 45 years Midazolam (IV) on day 1 |
|
| Male elderly adults | Experimental | Arm 2: Male healthy volunteers aged over 45 years Midazolam (IV) on day 1 |
|
| Female elderly adults | Experimental | Arm 3: Female healthy volunteers aged over 45 years Midazolam (IV) on day 1 |
|
| Female young adults | Experimental | Arm 4: Female healthy volunteers aged 20 to 45 years Midazolam (IV) on day 1, Day 15 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Midazolam I.V. | Drug | Midazolam I.V. 1mg/ml |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the curve of midazolam (AUC12h) | Pharmacokinetics of midazolam | Up to 12 hours after midazolam administration |
| Metabolic ratio of steroids | endogenous metabolite profiles such as steroid (6beta-hydroxy-cortisol/cortisol, 6beta-hydroxy-cortisone/cortisone) | 12h-12h |
| Clearance (CL) of midazolam | Pharmacokinetics of midazolam | Up to 12 hours after midazolam administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jieon Lee | Seoul | South Korea |
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