Table 2.

Geometric mean ratios for C_max and AUC and Hodges–Lehman estimate for t_max and their corresponding 90% confidence intervals for the comparisons between test and reference formulations in studies I (N=19) and II (N=22)

PK variable	Treatment comparison	Geometric mean ratio or Hodges–Lehman estimate	90% confidence interval
Study I
Cmax	A/C	0.85	0.69, 1.04
	B/C	0.78	0.64, 0.95
	D/B	0.81	0.56, 1.18
AUC0–∞	A/C	1.04	0.94, 1.14
	B/C	0.93	0.85, 1.03
	D/B	0.95	0.84, 1.07
tmax	A/C	0.1	−0.05, 0.6
	B/C	0.1	−0.5, 0.5
	D/B	−0.01	−0.4, 0.5
Study II
Cmax	B/A	0.19	0.16, 0.19
	C/A	0.36	0.31, 0.42
	C/B	2.23	1.88, 2.66
AUC0–24h	B/A	0.14	0.13, 0.16
	C/A	0.32	0.29, 0.35
	C/B	2.20	2.02, 2.40
tmax	B/A	0.2	0.0, 0.4
	C/A	0.1	−0.05, 0.2
	C/B	−0.1	−0.3, 0.1

Notes: Study I treatments: (A) a single 200 mg dose of a tablet formulation with increased crystal size administered as 2×100 mg, (B) a single 200 mg dose of a tablet formulation with increased crystal size and excipients in the extra-granular phase administered as 2×100 mg, (C) a single 200 mg dose of the old formulation used in previous studies administered as 2×100 mg, and (D) a single 200 mg dose of a tablet formulation with increased crystal size and excipients in the extra-granular phase administered as one 200 mg tablet. Study II treatments: (A) a single 200 mg dose of a tablet formulation with increased crystal size and excipients in the extra-granular phase administered as 2×100 mg (same as treatment B in study I); (B) 25 mg of a liquid-filled hard gelatin capsule; (C) 50 mg of a liquid-filled hard gelatin capsule administered as 2×25 mg capsules.

Abbreviations: AUC, area under the curve; C_max, maximum concentration; PK, pharmacokinetics; t_max, the median time to the maximum concentration.