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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02395926 | To Evaluate Safety and the Pharmacokinetic Characteristics After Oral Administration of HT-003 Compared With Choline Alfoscerate Capsule in Healthy Adult Male Volunteers | PHASE1 | COMPLETED | 24 | — | — | Oct 1, 2013 | Dec 1, 2013 | Mar 24, 2015 | - | — |
| Arm | Type | Description |
|---|---|---|
| R | ACTIVE_COMPARATOR | Gliatilin soft capsule 400mg, administration 3 times per 1day 8:00 a.m., 14:00, 20:00 |
| T1 | EXPERIMENTAL | HT-003 600mg, administration 2 times per 1 day 8:00 a.m., 20:00 |
| T2 | EXPERIMENTAL | HT-003 600mg\*2tab, administration 1 times per 1 day 8:00 a.m. |
| Name | Type | Description |
|---|---|---|
| Choline CR 600mg | DRUG | HT-003 600mg, administration 2 times per 1 day 8:00 a.m., 20:00 |
| Gliatilin 400mg | DRUG | Gliatilin soft capsule 400mg, administration 3 times per 1day 8:00 a.m., 14:00, 20:00 |
Inclusion Criteria: 1. Healthy male subjects between the ages of 20 and 55 years, inclusive 2. BMI\>=19kg/m2, \<=27kg/m2 \*body mass index (kg/m2) = weight (kg)/ \[(height (m)2) 3. Voluntary written consent by the parties that the ability and willingness to participate during the entire period ...