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Bioavailability of Amlodipine Besylate/Atorvastatin Calcium Combination Tablet

From Pfizer Inc, New York, New York (Dr Chung); Pfizer Inc, Groton, Connecticut (Mr Calcagni, Dr Glue); Pfizer Global Research and Development, Clinical Research Unit, Ann Arbor, Michigan (Dr Bramson).

The bioequivalence of combination tablets containing amlodipine besylate/atorvastatin calcium with coadministered matching doses of amlodipine besylate and atorvastatin calcium tablets was investigated in randomized, 2-way crossover studies in healthy volunteers (N = 126). Subjects received a single dose of the amlodipine/atorvastatin tablet or coadministered matching doses of amlodipine and atorvastatin at the highest (10/80 mg; n = 62) and lowest (5/10 mg; n = 64) dose strengths. Atorvastatin geometric mean ratios for maximum plasma concentration (C_max) and area under the plasma concentration–time curve (AUC) for the highest and lowest dose strengths were 94.1 and 98.8, and 104.5 and 103.8, respectively. Amlodipine geometric mean ratios for C_max and AUC for the highest and lowest dose strengths were 100.8 and 103.4, and 100 and 102.7, respectively. The 90% confidence intervals for all comparisons were within 80% to 125%, demonstrating bioequivalence for amlodipine and atorvastatin at both dose strengths. Use of amlodipine/atorvastatin combination tablets may provide a more integrated approach to treatment of cardiovascular risk.

Key Words: Amlodipine besylate • atorvastatin calcium • bioequivalence • combination tablet

Address for reprints: Candace Bramson, MD, Pfizer Global Research and Development, Ann Arbor Laboratories, 2800 Plymouth Road, Ann Arbor, MI 48105.

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