Pharmacokinetics and bioequivalence of two strontium ranelate formulations after single oral administration in healthy Chinese subjects.
Xenobiotica
; 49(4): 457-462, 2019 Apr.
Article
em En
| MEDLINE
| ID: mdl-29676197
ABSTRACT
Pharmacokinetics of exogenous strontium (Sr) and bioequivalence of a new oral formulation of strontium ranelate compared with the brand-name drug in healthy Chinese subjects was evaluated. A balanced, randomized, single-dose, two-treatment parallel study was conducted in 36 healthy Chinese subjects. Subjects were randomly allocated into two groups of 18 to receive a single oral dose of test formulation and reference formulation under a fasting state, respectively. Blood samples were collected at 19 designated time points up to 240-h post-dose. Serum concentrations of Sr were quantified by ICP-MS. A total of 36 subjects were enrolled and completed the study. Nine mild adverse events in 6 subjects were reported. The Cmax, AUC0-72 h, AUC0-t, and AUC0-∞ of test and reference formulations shown as mean ± SD were 6.97 ± 1.78 and 6.78 ± 1.80 µg/mL, 199 ± 51 and 187 ± 38 µg·h/mL, 303 ± 89 and 278 ± 54 µg·h/mL, and 337 ± 109 and 305 ± 60 µg·h/mL, respectively. Two formulations were bioequivalent, and both were generally well tolerated.
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Base de dados:
MEDLINE
Assunto principal:
Tiofenos
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Povo Asiático
Tipo de estudo:
Clinical_trials
Limite:
Adult
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Humans
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Male
Idioma:
En
Revista:
Xenobiotica
Ano de publicação:
2019
Tipo de documento:
Article