A bioequivalence study of lithium carbonate will be developed in 24 healthy subjects, in fasting condition
A bioequivalence study of lithium carbonate will be developed in 24 healthy subjects, in fasting condition, following the design: Open-label, crossover, randomized, single-dose design of 300 mg lithium carbonate immediate release tablets, with two treatments, two periods, two sequences in fasting condition, with a washout time of 14 days between each dose, participation as a subject in these studies implies a higher than minimal risk for the subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
24
Reference
Test
Centro de Atención e Investigación Médica
Bogotá, Cundinamarca, Colombia
AUC
concentration plasma under curve AUC
Time frame: 0 hours - 72 hours
Cmax
peak concentration plasma Cmax
Time frame: 0 hours - 6 hours
Tmax
Pharmacokinetic Outcome Measures
Time frame: 0 hours - 6 hours
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