- Bioequivalence Study of Atorvastatin Tablets in Healthy Pakistani Volunteers.
Bioequivalence Study of Atorvastatin Tablets in Healthy Pakistani Volunteers.
Therapie (2015-02-14)
Sohail Mohammad, Usman Arshad, Nasir Abbass, Irfan Parvez, Ghulam Abbas, Wajahat Mahmood
PMID25679187
RESUMEN
A two way, randomized cross-over bioequivalence study was conducted to analyse the rate and extent of absorption of atorvastatin after a single dose of 80 mg atorvastatin as atorvastatin calcium tablets. The study was carried out using healthy male volunteers (N = 24). A high performance liquid chromatography method was employed to determine the level of drug in human plasma. It was concluded that the test and the reference drug exhibited comparable values of pharmacokinetic parameters. It was also concluded that since there was no significant difference between the rate and extent of absorption of the drug from the test and the reference formulations: these two formulations could thus be declared bioequivalent.
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Sigma-Aldrich
Methanol solution, NMR reference standard, 4% in methanol-d4 (99.8 atom % D), NMR tube size 3 mm × 8 in.
Sigma-Aldrich
Acetonitrilo solution, contains 0.1 % (v/v) trifluoroacetic acid, suitable for HPLC
Supelco
Methanol solution, contains 0.10 % (v/v) formic acid, UHPLC, suitable for mass spectrometry (MS), ≥99.5%