Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
risedronate DR · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| 2 | EXPERIMENTAL | one commercial risedronate 35 mg DR tablet |
| 1 | ACTIVE_COMPARATOR | one Phase III risedronate 35 mg DR tablet |
| Name | Type | Description |
|---|---|---|
| risedronate DR (Phase III clinical supply) | DRUG | Reference - (Phase III clinical supply) one 35 mg DR tablet administered as a single oral dose after an overnight (10-hour) fast, followed by a 4-hour fast |
| risedronate 35 mg DR (Commercial Tablet) | DRUG | Test - (Commercial tablets) one 35 mg DR tablet administered as a single oral dose after an overnight (10-hour) fast, followed by a 4-hour fast |
Inclusion Criteria: * male or female, 18 to 65 years of age * if female, non-lactating and either surgically sterile or postmenopausal * body mass index less than or equal to 32 kg/m2 at screening Exclusion Criteria: * no use of a bisphosphonate within 1 month * no history of GI disease * no use ...