Comparative pharmacokinetic and pharmacodynamic evaluation of branded and generic formulations of meloxicam in healthy male volunteers

Figures & data

Table 1 Summary of baseline demographic characteristics in the study population of healthy male volunteers

Demographic characteristics	RT group (n = 12)	TR group (n = 12)	Overall study population (n = 24)	P*
Age, years	27.1 (3.8)	25.5 (4.5)	26.3 (4.1)	0.415
Height, m	1.76 (0.07)	1.81 (0.10)	1.79 (0.08)	0.187
Weight, kg	74.6 (7.8)	75.9 (11.1)	75.2 (9.3)	0.738
BMI, kg/m^2	24.0 (1.9)	23.1 (1.9)	23.6 (1.9)	0.260
SBP, mmHg	128.4 (8.3)	128.8 (9.1)	128.6 (8.5)	0.926
DBP, mmHg	73.3 (6.0)	77.0 (7.2)	75.2 (6.7)	0.188
Heart rate, beats/minute	66.9 (12.7)	76.5 (12.8)	71.7 (13.4)	0.080

Notes: Values are given as mean (standard deviation).

* RT versus TR. Subjects in the RT group received first the reference formulation (Mobic) and then the test formulation (Meloxicam Hexal). Subjects in the TR group received first the test formulation (Meloxicam Hexal) and then the reference formulation (Mobic).

Abbreviations: BMI, body mass index; SBP, systolic blood pressure; DBP, diastolic blood pressure.

Figure 1 Mean concentration-time profiles in plasma following the oral administration of 15 mg tablets of branded Mobic (•) or generic Meloxicam Hexal (□) formulation to healthy volunteers. Each point represents the geometric mean (95% confidence interval in vertical lines).

Table 2 Values of plasma pharmacokinetic parameters obtained from the study population of healthy male volunteers (n = 24) following the administration of generic (Meloxicam Hexal) and branded (Mobic) meloxicam formulations

	Meloxicam Hexal		Mobic
AUC(0–5) (mg × h/L)*	4.73 ± 0.42	4.29 (3.56–5.17)	4.29 ± 0.34	3.93 (3.31–4.68)
AUC(0–24) (mg × h/L)*	18.52 ± 1.65	16.97 (14.12–20.40)	18.49 ± 1.38	17.22 (14.55–20.39)
AUC(0–inf) (mg × h/L)*	31.44 ± 4.47	28.11 (22.06–35.81)	33.25 ± 4.03	27.85 (21.85–35.48)
Cmax (mg/L)*	1.32 ± 0.01	1.25 (1.07–1.45)	1.25 ± 0.09	1.18 (1.01–1.38)
Tmax (h)†	5.21 ± 0.59	4.00 (1.00–12.00)	5.75 ± 0.53	5.00 (4.00–12.00)
t½†	30.61 ± 5.35	17.83 (5.23–90.04)	38.05 ± 9.90	22.68 (6.12–233.51)

Notes:

* Data are reported as both arithmetic mean ± standard error, and geometric mean with 95% confidence interval;

† data are reported as both arithmetic mean ± standard error and median with 2.5 and 97.5 percentiles.

Abbreviations: AUC, area under the time–concentration curve; C_max, maximum plasma concentration; T_max, time to C_max; t_½, half-life; h, hours;

Table 3 Values of the ratios of AUC_0–5, AUC_0–24, AUC_0–inf, and C_max with 90% confidence intervals

	Meloxicam Hexal/Mobic
AUC0–5 (mg × h/L)	1.09 (0.92–1.30)
AUC0–24 (mg × h/L)	0.99 (0.84–1.16)
AUC0–inf (mg × h/L)	0.98 (0.81–1.19)
Cmax (mg/L)	1.05 (0.89–1.23)

Abbreviations: AUC, area under the time–concentration curve; C_max, maximum plasma concentration; h, hours;

Figure 2 Mechanical pain threshold (MPT) at 5 hours determined by a von Frey device over the two sessions on control (Z0) and hyperalgesic (Z1) skin zone. Each session was performed according to the crossover study design (period 1 and period 2). Data are expressed as means ± standard deviation (vertical lines).