Healthy Volunteer
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGADC189 tablet
ADC189 tablet, 45 mg, single oral dose in each Group. (Part 1 study)
DRUGADC189 granules
ADC189 granules, 45 mg, single oral dose in each Group. (Part 1 study)
DRUGADC189 180mg
ADC189 tablet, 180 mg, single oral dose. (Part 2 study)
Sponsors
Jiaxing AnDiCon Biotech Co.,Ltd
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* 1\. Healthy male subjects aged 18-45 years old * 2\. Male subjects weight over 50 kg
Exclusion criteria
* 1\. Any other clinically relevant abnormalities, concomitant diseases or ongoing medical conditions * 2\. Have a history of drug abuse in the past five years or use drugs in the three months prior to screening * 3\. Blood donation or blood loss \> 400 mL in 3 months before screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ADC189 Granules | 15 days | ADC189 plasma exposure, area under the concentration-time curve |
| ADC189 Tablet | 15 days | ADC189 plasma exposure, area under the concentration-time curve |
| ADC189 Ultra high dose | 15 days | Single dose of 180mg ADC189 tablet plasma exposure, area under the concentration-time curve |
Countries
China
Outcome results
None listed