Bioequivalence of Two Lithium Formulations in Healthy Volunteers

Abstract

All 90% and 95% confidence intervals were inside the limits defined by the FDA Guidance for Industry (80%-125%) and thus stated that test and reference formulation may be accepted as bioequivalent, with regard to both, maximum exposure and extent of bioavailability.

Population Pharmacokinetics of Lithium Carbonate in Young Male Healthy Chinese Volunteers

“…CL of carbonate lithium is mainly determined by the renal function of the subject and is less dependent on the parameter calculation method. The CL of lithium in healthy Chinese male subjects was mostly consistent with previously reported data in non-Chinese subjects [10]. A bioequivalence study of 2 lithium carbonate formulations carried out in Brazil reported a mean lithium AUC inf value of 25.22 mg * h/L after oral administration of a 300 mg dose, which was calculated by a non-compartment method using [10].…”