Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Indocin · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Indomethacin 75mg ER Capsules |
| 2 | ACTIVE_COMPARATOR | Indocin 75mg SR Capsules |
| Name | Type | Description |
|---|---|---|
| Indomethacin 75mg Extended-Release Capsules, Sandoz | DRUG | - |
| Indocin 75mg SR Capsules | DRUG | - |
Inclusion Criteria: * No clinically significant abnormal findings on physical exam, medical history or clinical laboratory results on screening Exclusion Criteria: * Positive test results for HIV or hepatitis B or C * No allergies to indomethacin or related drugs
Indocin is used for inflammation and is being studied in the immunology therapeutic area. It is a small molecule developed by Novartis AG. The clinical program includes one completed Phase 1 trial in 36 healthy adult volunteers, evaluating a 75mg extended-release capsule formulation.
Indocin is developed by Novartis AG, which trades under the ticker NVS. Novartis is the sponsor of the clinical program for Indocin, including the Phase 1 relative bioavailability study of the 75mg extended-release capsule formulation.
Indocin is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are ongoing. The completed study was a relative bioavailability study of 75mg Indomethacin extended-release capsules in 36 healthy volunteers.
Indocin has been evaluated in one completed Phase 1 trial, NCT00858195, titled A Relative Bioavailability Study of 75mg Indomethacin Extended-Release Capsules. The trial enrolled 36 healthy adult volunteers of all sexes, was randomized and active-controlled, and studied inflammation.