Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Alendronate · 1 trial · 1 indication
| 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...
Alendronate is a small molecule drug being studied in healthy volunteers. It is currently in Phase 1 clinical development by Dr. Reddy's Laboratories Ltd. The drug is being investigated for its bioequivalence, meaning how well a generic version compares to a reference product.
Alendronate is being developed by Dr. Reddy's Laboratories Ltd, a pharmaceutical company listed on the stock exchange under the ticker RDY. The company is conducting clinical trials to evaluate the drug's bioequivalence in healthy subjects.
Alendronate is in Phase 1 clinical development. It is an investigational drug, not yet approved by regulatory authorities. The current trial is a bioequivalence study, which is an early-stage study typically conducted to support generic drug applications.
Alendronate has one completed clinical trial, NCT01133496, titled 'Bioequivalence Study of Alendronate Sodium Tablets 70 mg of Dr. Reddy's Under Fasting Conditions.' This Phase 1 study enrolled 80 healthy volunteers in India and was active-controlled, meaning it compared the test drug to a reference product.
Alendronate is the active ingredient in the drug product, which is formulated as alendronate sodium tablets. The clinical trial NCT01133496 specifically studied alendronate sodium tablets at a 70 mg dose, indicating that alendronate and alendronate sodium refer to the same medication.