Pharmacokinetics of a new oral formulation of amoxicillin.
The bioavailability of the recently developed 1 g dispersible tablet form of amoxicillin (B) and the 1 g dispersible tablet in suspension form (C) were compared to that of the 1 g standard reference formulation (A). Twelve healthy volunteers were involved in this single-dose, open, randomized, three-way cross-over study. The mean peak serum levels were 14.1 +/- 4.1 micrograms/ml after A, 15.1 +/- 3.1 micrograms/ml after B and 15.1 +/- 5.4 micrograms/ml after C. The area under the drug concentration versus time curves were 47.6 +/- 12.0 micrograms.h/ml after A, 52.8 +/- 10.2 micrograms.h/ml after B and 51.1 +/- 13.8 micrograms.h/ml after C. On the basis of these two pharmacokinetic parameters, the three formulations were found to be bioequivalent. In addition, the predicted serum concentrations during multiple dosing (3 times a day), derived from the corresponding mean concentrations after a single 1 g dose of C showed that 8 hourly administration would yield therapeutic serum concentrations for infections such as uncomplicated community-acquired pneumonia due to susceptible or less susceptible strains in otherwise healthy subjects.
Prevot
M H
MH
Département de pharmacologie clinique, hŏpital Bichat Claude Bernard, Paris, France.
Jehl
F
F
Rouveix
B
B
D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000658:Amoxicillin / Q000008:administration & dosage / Q000097:blood / Q000493:pharmacokinetics*; D000704:Analysis of Variance; D019540:Area Under Curve; D001682:Biological Availability; D004334:Drug Administration Schedule; D005260:Female; D006207:Half-Life; D006801:Humans; D008297:Male; D008875:Middle Aged; D010406:Penicillins / Q000008:administration & dosage / Q000097:blood / Q000493:pharmacokinetics*
D010406:Penicillins; D000658:Amoxicillin