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- W2550466263 abstract "Purpose: An orally disintegrating tablet (ODT) of amlodipine has been developed for the benefit of patients who have difficulty swallowing solid dosage forms. Methods: Two pivotal bioequivalence studies of amlodipine ODT given with and without water, versus either amlodipine tablets or capsules, were conducted in 36 subjects each. Both studies were randomized, open-label, crossover, single-dose (10 mg) studies in healthy subjects ages 18 to 55 years. Plasma samples were collected for 168 hours post dose and pharmacokinetics were determined by non-compartmental analyses. Results: Amlodipine ODT with or without water was bioequivalent to amlodipine tablets as the ratio (90% CI) of Cmax, AUC∞, and AUClast were contained within 80–125%. Amlodipine ODT with or without water was also bioequivalent to amlodipine capsules as the ratio (90% CI) of Cmax, AUC∞, and AUClast were contained within 80–125%. Conclusion: Amlodipine ODT, given with or without water, provides equivalent systemic exposure compared to amlodipine tablets or capsules." @default.
- W2550466263 created "2016-11-30" @default.
- W2550466263 creator A5084489498 @default.
- W2550466263 date "2016-01-01" @default.
- W2550466263 modified "2023-10-17" @default.
- W2550466263 title "Pharmacokinetics of a Novel Orodispersible Tablet of Amlodipine in Healthy Subjects" @default.
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- W2550466263 doi "https://doi.org/10.4172/jbb.1000138" @default.
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