Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04907006 | A Food-drug Interaction Study of SY-004 in Healthy Subjects | PHASE1 | COMPLETED | 24 | — | — | Aug 31, 2021 | Oct 11, 2021 | May 18, 2022 | 1 | China |
Under fasting and high-fat diet, Area under the plasma concentration versus time curve (AUC) 0-t of SY-004 in human plasma.
Under fasting and high-fat diet, Area under the plasma concentration versus time curve (AUC)0 - ∞ of SY-004 in human plasma.
Under fasting and high-fat diet, Peak Plasma Concentration (Cmax) of SY-004 in human plasma.
| Arm | Type | Description |
|---|---|---|
| Group-1 | EXPERIMENTAL | The subjects in both groups will be fasting overnight for at least 10 hours before administration. In Group-1 on D1, subjects will be orally administered with one SY-004 capsule(80mg ) on an empty stomach with 240ml warm water; In Group-2, subjects will have high-fat breakfast 30 minutes before administration ,then take one SY-004 capsule(80mg) orally with 240ml warm water. The subjects in both groups will be fasted within 4 hours after taking the medicine, and drinking water is forbidden within 1 hour before and after taking the medicine. After the cleaning period (D9-D16), the subjects will exchang the way of taking medicine and enter the second cycle of drug administration. |
| Group-2 | EXPERIMENTAL | The subjects in both groups will be fasting overnight for at least 10 hours before administration. In Group-1 on D1, subjects will be orally administered with one SY-004 capsule(80mg ) on an empty stomach with 240ml warm water; In Group-2, subjects will have high-fat breakfast 30 minutes before administration ,then take one SY-004 capsule(80mg) orally with 240ml warm water. The subjects in both groups will be fasted within 4 hours after taking the medicine, and drinking water is forbidden within 1 hour before and after taking the medicine. After the cleaning period (D9-D16), the subjects will exchang the way of taking medicine and enter the second cycle of drug administration. |
| Name | Type | Description |
|---|---|---|
| SY-004 capsule | DRUG | After fasting for 10 hours, subjects in group 1 took one SY-004 (80mg) orally on an empty stomach on the day of administration with 240ml warm water; Subjects in group 2 began to eat high-fat breakfast 30 minutes before administration , and took one SY-004 capsule（80mg） orally with 240ml warm water. The subjects in both groups were fasted within 4 hours after taking the medicine, and drinking water was forbidden within 1 hour before and after taking SY-004. |
Inclusion Criteria: * The subjects can communicate well with the researchers, understand and comply with the requirements of this study, and sign the informed consent voluntarily. * Age on the day of signing the informed consent: healthy subjects aged 18 or above, both male and female. * At the tim...