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Part 1 of this study will compare the pharmacokinetic performance of tablet and granule formulations of ADC189 under fasted conditions in healthy volunteers. A randomized, two-period, two-treatment crossover design is used. In each period, each volunteer will receive a single oral dose of the tablet or granule formulation without food.
The purpose of Part 2 study is to determine the safety and pharmacokinetics of ultra high dose of ADC189 in healthy subjects.
In Part 1 study, a total of 32 subjects were randomly divided into two groups, A and B, with 16 subjects in each group. After a 28-day screening period, on the first day of Period 1 (D1), subjects in group A took ADC189 granules (a single oral dose, 45mg), and subjects in group B took ADC189 tablets (a single oral dose, 45mg), all subjects were under fasted conditon. In Period 2, two groups will change to the fomulation which is different in Period 1 respectively, and all the steps will keep the same as Period 1. Each period lasts for 15 days, and have a 7-day interval between 2 periods. Blood samples will be taken, pharmacokinetic and saftey profiles will be observed.
In Part 2 study, the ultra high dose of ADC189 (a single oral dose, 180mg) will applied in 8 healty adult male subjects. The pharmacokinetic and saftey profiles will be observed during the following 15 days, and blood sample will be taken.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ADC189 tablet Group A | Experimental | 16 patients. |
|
| ADC189 granules Group B | Experimental | 16 patients. |
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| ADC189 180mg Group | Experimental | 8 patients. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ADC189 tablet | Drug | ADC189 tablet, 45 mg, single oral dose in each Group. (Part 1 study) |
|
| Measure | Description | Time Frame |
|---|---|---|
| ADC189 Granules | ADC189 plasma exposure, area under the concentration-time curve | 15 days |
| ADC189 Tablet | ADC189 plasma exposure, area under the concentration-time curve | 15 days |
| ADC189 Ultra high dose | Single dose of 180mg ADC189 tablet plasma exposure, area under the concentration-time curve | 15 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhao Wei | Jinan | Shang Dong | 250000 | China |
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| ADC189 granules | Drug | ADC189 granules, 45 mg, single oral dose in each Group. (Part 1 study) |
|
| ADC189 180mg | Drug | ADC189 tablet, 180 mg, single oral dose. (Part 2 study) |
|