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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 developed by Dr. Reddy's Laboratories Ltd, which trades under the ticker RDY. It is also known as Alendronate Sodium Tablets, 70 mg. The listed development stage is Phase 1, and the program's stated indication is undisclosed.
Alendronate targets FDPS, which stands for farnesyl diphosphate synthase. It acts as an inhibitor of that target. FDPS is the enzyme the drug is designed to bind and inhibit, which is the mechanism described for this small molecule asset.
Alendronate is developed by Dr. Reddy's Laboratories Ltd, a company whose shares trade under the ticker RDY. Dr. Reddy's is the sponsor listed for the clinical program, including the bioequivalence study of Alendronate Sodium Tablets 70 mg conducted under fasting conditions.
Alendronate is in Phase 1 development. It is an investigational asset and is not described as approved. The program has one recorded trial, which is completed, with no active trials currently listed. That trial enrolled 80 participants.
Alendronate has been studied in one recorded trial, NCT01133496, titled Bioequivalence Study of Alendronate Sodium Tablets 70 mg of Dr. Reddy's Under Fasting Conditions. It was a Phase 1, completed, randomized, active-controlled study with 80 healthy volunteers in India, aged 18 years and older, of all sexes.