The objective of this study is to investigate the bioequivalence of Mylan's alendronate sodium 70 mg tablets to Merck's Fosamax 70 mg tablets following a single, oral 70 mg (1 x 70 mg) dose administration under fasting conditions.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Enrollment
110
1 x 70 mg, single-dose fasting
1 x 70 mg, single-dose fasting
PRACS Insitute Ltd.
Fargo, North Dakota, United States
The 90% confidence interval for the LSMeans ratio of CPEAK, AUCL, and AUCI for the test and reference product should be between 80.00% and 125.00% for the natural log-transformed data.
Time frame: urine collection up to 36 hours
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