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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.
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alendronate Sodium Tablets 70mg | Drug | 1 x 70mg, single dose fasting |
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| Measure | Description | Time Frame |
|---|---|---|
| Bioequivalence Based on Rmax | Rmax = maximum rate of urinary excretion | Urine collected over 36 hour period |
| Bioequivalence Based on Ae0-36 | Ae0-36 = cumulative urine excretion | Urine collected over 36 hour period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eric Masson, Pharm.D. | Anapharm | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anapharm Inc. | Sainte-Foy | Quebec | GIV2K8 | Canada |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
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| Period: First Intervention |
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| Period: Washout of 7 Days |
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| Period: Second Intervention |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Fosamax® First |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Bioequivalence Based on Rmax | Rmax = maximum rate of urinary excretion | Posted | Geometric Mean | Standard Deviation | ng/mL | Urine collected over 36 hour period |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Manager, Biopharmaceutics | TEVA Pharmaceuticals USA | 1-866-384-5525 | clinicaltrialqueries@tevausa.com |
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| ID | Term |
|---|---|
| D019386 | Alendronate |
| ID | Term |
|---|---|
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
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| Fosamax® Tablets 70mg |
| Drug |
1 x 70 mg, single dose fasting |
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| NOT COMPLETED |
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| NOT COMPLETED |
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70 mg Fosamax® Tablets reference product dosed in first period followed by 70 mg Alendronate Sodium Tablets test product dosed in second period.
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Participants |
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| Primary | Bioequivalence Based on Ae0-36 | Ae0-36 = cumulative urine excretion | Posted | Geometric Mean | Standard Deviation | ng/mL | Urine collected over 36 hour period |
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Principal Investigator is not permitted to discuss or publish trial results.