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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05519514 | Bio-Equivalence Study of Budesonide Prolonged-release Tablets 9 Mg In Healthy Human Adult Subjects | PHASE1 | COMPLETED | 56 | — | — | Jul 12, 2021 | Nov 15, 2021 | Aug 29, 2022 | 1 | India |
Cmax (Maximum plasma concentration)
AUC0-t (area under the curve)
| Arm | Type | Description |
|---|---|---|
| Cortiment (Budesonide 9 mg prolonged release tablet) | ACTIVE_COMPARATOR | - |
| Budesonide 9 mg prolonged release tablet | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Cortiment | DRUG | Budesonide 9 mg prolonged release tablets |
| Budesonide | DRUG | Experimental (Budesonide 9 mg prolonged release tablets) |
Inclusion Criteria: 1. Normal healthy human adult male and non- pregnant female volunteers between 18-45 years (both ages inclusive) of age. 2. Who is given written informed consent and are willing to participate in the study. 3. Body Mass Index of 18.50 to 30.00 Kg/m2 (both inclusive). 4. No evide...