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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03860532 | Phase I Clinical Trial in Healthy Male Volunteers | PHASE1 | COMPLETED | 24 | — | — | Sep 1, 2011 | Dec 1, 2011 | Mar 5, 2019 | - | — |
Peak Plasma Concentration (Cmax) of HMPL-011 tablets (600 mg tablet X 2) and capsules (200 mg capsule X 6) in fasted States.
Peak Plasma Concentration (Cmax) of HMPL-011 tablets (600 mg tablet X 2) and capsules (200 mg capsule X 6) in fed States.
Steady State concentration of HMPL-011 will be caculated based on Ctrough
Area under the plasma concentration versus time curve (AUC) of HMPL-011 tablets (600 mg tablet X 2) and capsules (200 mg capsule X 6) in fed States.
Area under the plasma concentration versus time curve (AUC) of HMPL-011 tablets (600 mg tablet X 2) and capsules (200 mg capsule X 6) in fasted States.
| Arm | Type | Description |
|---|---|---|
| HMPL-011 tablets | ACTIVE_COMPARATOR | A sigle total oral dose of 1200 mg tablets (600 mg tablet X 2) |
| HMPL-011 capsules | ACTIVE_COMPARATOR | A sigle total oral dose of 1200 mg capsules (200 mg tablet X 6) |
| Name | Type | Description |
|---|---|---|
| HMPL-011 tablets | DRUG | Eligible subjects will recieve 1200 mg HMPL-011 tablets under fed and diet circumstance. |
| HMPL-011 capsules | DRUG | Eligible subjects will recieve 1200 mg HMPL-011 capsules under fed and diet circumstance. |
Inclusion Criteria: Subjects meeting the following criteria at the Screening Visit will be eligible to participate in the study: * Healthy adult male and female subjects, 18-70 years of age, inclusive, at the time of signing the informed consent; * Body weight ≥ 50 kg and body mass index (BMI) wit...