The relative bioavailability of 2 prototype fixed-dose combination formulations for amlodipine and rosuvastatin in healthy white and Chinese subjects
Autor: | Jonathan Bullman, Shashidhar Joshi, Shiva G. Kapsi, Htar H. Nwe, Annie Stylianou |
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Rok vydání: | 2015 |
Předmět: |
medicine.medical_specialty
business.industry Fixed-dose combination Cmax Urology nutritional and metabolic diseases Pharmaceutical Science 030204 cardiovascular system & hematology Pharmacology Bioequivalence 030226 pharmacology & pharmacy Crossover study 03 medical and health sciences Rosuvastatin Calcium 0302 clinical medicine Tolerability medicine Pharmacology (medical) Rosuvastatin Amlodipine business medicine.drug |
Zdroj: | Clinical Pharmacology in Drug Development. 5:131-140 |
ISSN: | 2160-763X |
Popis: | A fixed-dose combination (FDC) may improve patient compliance and clinical outcomes in the management of cardiovascular risk in hypertensive and dyslipidemic patients. The study (NCT02075619) evaluated the bioavailability of 2 prototype FDC tablet formulations (FDC1 and FDC2) of amlodipine/rosuvastatin (10 mg/20 mg) compared with coadministered reference tablets. It was a randomized, single-dose, 3-way crossover pilot study in healthy white (n = 12) and Chinese (n = 12) adults. Three treatments (FDC1, FDC2, and reference) were administered after fasting with a washout period of 12-17 days. The pharmacokinetics of amlodipine and rosuvastatin were studied for all subjects (pooled) and by ethnicity. Safety and tolerability were also evaluated. Both FDCs met the bioequivalence criteria (90% confidence intervals falling within the range of 0.80-1.25) for AUC0-t and Cmax for amlodipine and rosuvastatin. Intrasubject variability (AUC0-t and Cmax ) was in the region of 23%-25% for rosuvastatin and 7%-10% for amlodipine. The FDC formulations demonstrated similar bioavailability to coadministered commercially available amlodipine and rosuvastatin. All treatments were generally well tolerated. |
Databáze: | OpenAIRE |
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