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Single-dose and steady-state studies were carried out on separate occasions to examine the bioequivalence of the newly formulated carbamazepine chewable tablet. In the single-dose study, the plasma levels resulting from 2 X 200-mg conventional tablets (CT), 4 X 100-mg chewable tablets swallowed whole (SW), and 4 X 100-mg chewable tablets chewed before swallowing (CHEW) were compared. A randomized 3 X 3 Latin-square design balanced for residual effects, with a 3-week washout period, was used (n = 6). Plasma samples were analyzed by a specific GC method for carbamazepine. The following parameters were used for evaluation: AUC, Cmax, tmax, and t1/2. None of the parameters were significantly different except Cmax and t1/2 values for CHEW and CT. The Cmax was 25% higher and t1/2 was 11% shorter for CHEW than CT. The impact of differences in the peak plasma levels at steady state were examined by pharmacokinetic projection (400 mg b.i.d.) based on the single-dose data and with simulated induction equal to a 50% reduction in t1/2. The projected steady-state CT and CHEW plasma concentrations were similar, with a difference of only 4%. The results demonstrate the bioequivalence of the dosage forms with respect to the extent of absorption, and similar steady-state concentrations of carbamazepine in plasma can be expected. To test the conclusion from the projected study, a separate bioequivalence study to compare CHEW relative to CT was performed at steady state in normal volunteers (200 mg b.i.d.).(ABSTRACT TRUNCATED AT 250 WORDS)
K K Chan, and
R J Sawchuk, and
T A Thompson, and
E Redalieu, and
W E Wagner, and
A R LeSher, and
B J Weeks, and
N R Hall, and
A Gerardin
May 2005,
Current medical research and opinion,
K K Chan, and
R J Sawchuk, and
T A Thompson, and
E Redalieu, and
W E Wagner, and
A R LeSher, and
B J Weeks, and
N R Hall, and
A Gerardin
September 2012,
Biomedica : revista del Instituto Nacional de Salud,
K K Chan, and
R J Sawchuk, and
T A Thompson, and
E Redalieu, and
W E Wagner, and
A R LeSher, and
B J Weeks, and
N R Hall, and
A Gerardin
January 1989,
Biopharmaceutics & drug disposition,
K K Chan, and
R J Sawchuk, and
T A Thompson, and
E Redalieu, and
W E Wagner, and
A R LeSher, and
B J Weeks, and
N R Hall, and
A Gerardin
January 1987,
Biopharmaceutics & drug disposition,
K K Chan, and
R J Sawchuk, and
T A Thompson, and
E Redalieu, and
W E Wagner, and
A R LeSher, and
B J Weeks, and
N R Hall, and
A Gerardin
March 1999,
Pharmacological research,
K K Chan, and
R J Sawchuk, and
T A Thompson, and
E Redalieu, and
W E Wagner, and
A R LeSher, and
B J Weeks, and
N R Hall, and
A Gerardin
September 2023,
Scientific reports,
K K Chan, and
R J Sawchuk, and
T A Thompson, and
E Redalieu, and
W E Wagner, and
A R LeSher, and
B J Weeks, and
N R Hall, and
A Gerardin
September 2009,
Phytotherapy research : PTR,
K K Chan, and
R J Sawchuk, and
T A Thompson, and
E Redalieu, and
W E Wagner, and
A R LeSher, and
B J Weeks, and
N R Hall, and
A Gerardin
January 1993,
Epilepsia,
K K Chan, and
R J Sawchuk, and
T A Thompson, and
E Redalieu, and
W E Wagner, and
A R LeSher, and
B J Weeks, and
N R Hall, and
A Gerardin
July 2015,
Clinical therapeutics,
K K Chan, and
R J Sawchuk, and
T A Thompson, and
E Redalieu, and
W E Wagner, and
A R LeSher, and
B J Weeks, and
N R Hall, and
A Gerardin
September 2013,
Drug research,
