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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00835406 | Alendronate Sodium 70 mg Tablet Versus Fosamax® Under Fasting Conditions. | PHASE1 | COMPLETED | 140 | — | — | Jun 1, 2000 | Jul 1, 2000 | Jul 9, 2009 | 1 | Canada |
Rmax = maximum rate of urinary excretion
Ae0-36 = cumulative urine excretion
| Arm | Type | Description |
|---|---|---|
| Alendronate Sodium First | EXPERIMENTAL | 70 mg Alendronate Sodium Tablets test product dosed in first period followed by 70 mg Fosamax® Tablets reference product dosed in second period |
| Fosamax® First | ACTIVE_COMPARATOR | 70 mg Fosamax® Tablets reference product dosed in first period followed by 70 mg Alendronate Sodium Tablets test product dosed in second period. |
| Name | Type | Description |
|---|---|---|
| Alendronate Sodium Tablets 70mg | DRUG | 1 x 70mg, single dose fasting |
| Fosamax® Tablets 70mg | DRUG | 1 x 70 mg, single dose fasting |
Inclusion Criteria: * Subjects will be males, non-smokers, between 18 and 45 years of age. * Subjects' weight will be within 15% of their ideal body weight based on the Table of "Desirable Weight of Adults", Metropolitan Life Insurance Company, 1983 * Subjects should read, sign, and date an Informe...