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| Sponsor: | Teva Pharmaceuticals USA |
|---|---|
| Information provided by: | Teva Pharmaceuticals USA |
| ClinicalTrials.gov Identifier: | NCT00835406 |
Purpose
The objective of this study is to compare the rate and extent of absorption of alendronate sodium 70 mg tablets (test) versus Fosamax® 70 mg tablets (reference) administered as a single dose of 70 mg under fasting conditions. A review of pharmacokinetic data demonstrates Alendronate Sodium Tablets, 70 mg, manufactured and distributed by TEVA Pharmaceuticals USA are bioequivalent to Fosamax® Tablets, 70 mg, manufactured by Merck Sharp & Dohme, USA.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: Alendronate Sodium Tablets 70mg Drug: Fosamax® Tablets 70mg |
Phase I |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Crossover Assignment Masking: Open Label |
| Official Title: | Randomized, 2-Way Crossover, Bioequivalence Study of Teva Pharmaceuticals USA and Merck Sharp & Dohme (USA) (Fosamax®) Alendronate Sodium Tablets Administered as a 1 x 70 mg in Healthy Adult Males Under Fasting Conditions |
| Enrollment: | 140 |
| Study Start Date: | June 2000 |
| Study Completion Date: | July 2000 |
| Primary Completion Date: | July 2000 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Alendronate Sodium First
70 mg Alendronate Sodium Tablets test product dosed in first period followed by 70 mg Fosamax® Tablets reference product dosed in second period
|
Drug: Alendronate Sodium Tablets 70mg
1 x 70mg, single dose fasting
|
|
Active Comparator: Fosamax® First
70 mg Fosamax® Tablets reference product dosed in first period followed by 70 mg Alendronate Sodium Tablets test product dosed in second period.
|
Drug: Fosamax® Tablets 70mg
1 x 70 mg, single dose fasting
|
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| ClinicalTrials.gov Identifier: | NCT00835406 History of Changes |
| Other Study ID Numbers: | 00161 |
| Study First Received: | January 30, 2009 |
| Results First Received: | April 24, 2009 |
| Last Updated: | June 29, 2009 |
| Health Authority: | United States: Institutional Review Board |
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Bioequivalence Healthy Subjects |
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Alendronate Bone Density Conservation Agents Physiological Effects of Drugs Pharmacologic Actions |