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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01133496 | Bioequivalence Study of Alendronate Sodium Tablets 70 mg of Dr. Reddy's Under Fasting Conditions | PHASE1 | COMPLETED | 80 | — | — | Dec 1, 2006 | Apr 1, 2007 | Jun 14, 2010 | 1 | India |
| Arm | Type | Description |
|---|---|---|
| Alendronate Sodium | EXPERIMENTAL | Alendronate Sodium Tablets, 70 mg of Dr. Reddy's |
| Fosamax | ACTIVE_COMPARATOR | Fosamax Tablets 70 mg of Merck \& Company. Inc., USA. |
| Name | Type | Description |
|---|---|---|
| Alendronate Sodium Tablets, 70 mg | DRUG | Alendronate Sodium Tablets, 70 mg of Dr. Reddy's Laboratories Limited. |
Inclusion Criteria: 1. Healthy human subjects aged between 18 and 45 years (including both). 2. Subjects with a BMI between 18.5 - 24.9 Kg/m2 but weight not less than 45 Kgs. 3. Female subjects who are postmenopausal or surgically sterile. 4. Female subjects of child bearing potential practicing an...