Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Alendronate · 2 trials · 1 indication
| 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...
Alendronate is a small molecule drug being developed by Viatris Inc. for use in healthy volunteers. It is currently in Phase 1 clinical development, with studies evaluating the drug in healthy individuals. The drug is being studied as a potential treatment, though specific approved indications are not detailed.
Alendronate is developed by Viatris Inc., a company traded on the stock exchange under the ticker VTRS. The company is conducting clinical trials to evaluate the drug's effects in healthy volunteers. Viatris is responsible for the drug's development and regulatory pathway.
Alendronate is in Phase 1 clinical development. It has completed two Phase 1 trials, both of which were fasting studies comparing Alendronate sodium tablets to Fosamax tablets in healthy volunteers. The drug is still in the early stages of clinical investigation and is not yet approved.
Alendronate has been studied in two completed Phase 1 clinical trials. The first trial, NCT00983996, compared Alendronate sodium tablets (10 mg) to Fosamax tablets (10 mg) in 112 healthy participants. The second trial, NCT01012934, compared Alendronate sodium tablets (70 mg) to Fosamax tablets (70 mg) in 110 healthy participants. Both trials were conducted in the United States.
Alendronate is being studied in comparison to Fosamax, which is a brand-name version of alendronate sodium. The clinical trials are designed to test whether the generic alendronate tablets are equivalent to the branded Fosamax tablets. Both contain the same active ingredient, alendronate sodium.