Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Alendronate · 1 trial · 1 indication
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...
Alendronate is a small molecule drug being studied in healthy volunteers. It is currently in Phase 1 clinical development, with a completed trial evaluating its effects under fasting conditions. The drug is being developed by Teva Pharmaceutical Industries Limited.
Alendronate is being developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. The company is conducting clinical research on this small molecule drug, which is currently in Phase 1 development.
Alendronate is in Phase 1 clinical development. A Phase 1 trial has been completed, which studied the drug in healthy male volunteers. The drug is investigational and has not been approved for any use.
Alendronate has one completed clinical trial, NCT00835406, titled "Alendronate Sodium 70 mg Tablet Versus Fosamax® Under Fasting Conditions." This Phase 1 study enrolled 140 healthy male participants in Canada and was an active-controlled trial.
Alendronate was studied in a clinical trial comparing it to Fosamax, a brand-name product. The trial, NCT00835406, evaluated Alendronate Sodium 70 mg tablets against Fosamax under fasting conditions in healthy volunteers.