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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01012934 | Fasting Study of Alendronate Sodium Tablets (70 mg) and Fosamax Tablets (70 mg) | PHASE1 | COMPLETED | 110 | — | — | Jul 1, 2002 | Aug 1, 2002 | Nov 13, 2009 | 1 | United States |
| NCT00983996 | Fasting Study of Alendronate Sodium Tablets (10 mg) and Fosamax Tablets (10 mg) | PHASE1 | COMPLETED | 112 | — | — | Jun 1, 2002 | Jul 1, 2002 | Sep 24, 2009 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Alendronate Sodium Tablets, 70 mg |
| 2 | ACTIVE_COMPARATOR | Fosamax Tablets, 70 mg |
| Name | Type | Description |
|---|---|---|
| Alendronate Sodium Tablets, 70 mg | DRUG | 1 x 70 mg, single-dose fasting |
| Fosamax Tablets, 70 mg | DRUG | 1 x 70 mg, single-dose fasting |
| Alendronate Sodium Tablets, 10 mg | DRUG | 10 mg, single-dose fasting |
| Fosamax Tablets, 10 mg | DRUG | 10 mg, single-dose fasting |
Inclusion Criteria: * healthy, adult subjects, 18 years and older * able to swallow medication Exclusion Criteria: * institutionalized subjects * history of any significant disease * use of any prescription or OTC medications within 14 days of start of study * received any investigational product...