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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00913250 | A Bioequivalence Study of Serum Free Avonex and Serum Containing Avonex in Healthy Volunteers | PHASE1 | COMPLETED | 96 | — | — | Aug 1, 2003 | Oct 1, 2003 | Jun 4, 2009 | - | — |
| Arm | Type | Description |
|---|---|---|
| Sequence 1 | EXPERIMENTAL | Serum containing Avonex followed by serum free Avonex |
| Sequence 2 | EXPERIMENTAL | Serum free Avonex followed by serum containing Avonex |
| Name | Type | Description |
|---|---|---|
| Serum containing Avonex | DRUG | 60mcg IM dose of serum containing Avonex on Day 1, followed by 60mcg IM dose of serum free Avonex on Day 15 |
| Serum Free Avonex | DRUG | 60mcg IM dose of serum free Avonex on Day 1, followed by 60mcg IM dose of serum containing Avonex on Day 15. |
Inclusion Criteria: * Healthy Volunteers Exclusion Criteria: * History of severe allergic or anaphylactic reactions * History of hypersensitivity to acetaminophen (paracetamol), ibuprofen, or codeine. * Known allergy to dry natural rubber * History of seizure disorder or unexplained blackouts * H...