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The primary objective of the study was to assess the effect of High Fat Diet on the pharmacokinetics of KC1036 in Chinese adult healthy subjects.
This is an open-label, randomized, two cycle self crossover experimental design study to assess the effect of High Fat Diet on the pharmacokinetics, material balance, safety of KC1036 in Chinese adult healthy subjects. This study was divided into two Groups A and B.
Group A:In the fasting state, KC1036 po only once (60mg QD) and after 7 days, in the high fat diet state, KC1036 po only once (60mg QD).
Group B:In the high fat diet state, KC1036 po only once (60mg QD) and after 7 days, in the fasting state, KC1036 po only once (60mg QD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | In the fasting state, KC1036 po only once (60mg QD) and after 7 days,in the high fat diet state,KC1036 po only once (60mg QD). |
|
| Group B | Experimental | In the high fat diet state, KC1036 po only once (60mg QD) and after 7 days, in the fasting state, KC1036 po only once (60mg QD). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KC1036 | Drug | 60mg QD |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK) profile: Cmax | Peak Plasma Concentration | up to 13 Days |
| Pharmacokinetics (PK) profile: Tmax | Time to reach the maximum plasma concentration | up to 13 Days |
| Pharmacokinetics (PK) profile: T1/2 | Terminal half-life | up to 13 Days |
| Pharmacokinetics (PK) profile: AUC | Area under the single-dose plasma concentration-time curve | up to 13 Days |
| Measure | Description | Time Frame |
|---|---|---|
| material balance | Drug recovery | up to 13 Days |
| Adverse events (AEs) | Incidence of treatment-related AEs | up to 43 Days |
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Inclusion Criteria:
Exclusion Criteria:
Male
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China Hospital of Sichuan University | Chengdu | Sichuan | 610041 | China |
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Double cycle, self crossover
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