Bioequivalence of two lithium formulations in healthy volunteers.
OBJECTIVE
The purpose of this study was to compare the maximum exposure and extent of bioavailability of two lithium carbonate (CAS 554-13-2) containing 300 mg tablet formulations (test and reference) for oral administration.


METHODS
This bioequivalence study was conducted in a 2-period crossover design with a washout phase of 7 days. Plasma samples were obtained by blood sampling over 72 h in each period. Twenty-four healthy volunteers of both genders participated in the trial. Samples were analyzed by a flame atomic absorption spectrometer. Resulting Li+ concentrations were used for determination of the pharmacokinetic parameters AUC(last), AUC(inf) and C(max).


RESULTS
90 % confidence intervals for AUC(last), AUC(inf) and C(max) were 96.81-107.44%, 98.44-109.54% and 98.60-111.33%, respectively.


CONCLUSIONS
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.
Guilherme
Márcia Cristina
MC
Galeno Research Unit, St. Campinas, Sao Paulo, Brazil.
Pereira
Dárcio Gomes
DG
Galuppo
Miriam Prado
MP
Mendes
Gustavo D
GD
Donato
José Luiz
JL
De Nucci
Gilberto
G
D000328:Adult; D018692:Antimanic Agents / Q000008:administration & dosage* / Q000097:blood / Q000493:pharmacokinetics*; D019540:Area Under Curve; D002138:Calibration; D002626:Chemistry, Pharmaceutical; D018592:Cross-Over Studies; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D016651:Lithium Carbonate / Q000008:administration & dosage* / Q000097:blood / Q000493:pharmacokinetics*; D008297:Male; D008875:Middle Aged; D011786:Quality Control; D013810:Therapeutic Equivalency
D018692:Antimanic Agents; D016651:Lithium Carbonate