BIOEQUIVALENCE STUDY OF FIXED DOSE COMBINATION TABLET CONTAINING LORNOXICAM AND THIOCOLCHICOSIDE IN HEALTHY SUBJECTS

The study was designed to determine the relative bioavailability of two sustained release Fixed dose combination (FDC) products of two manufacturers containing Lornoxicam [CAS No. 70374-39-9] 8mg and Thiocolchicoside [CAS No. 602-41-5] 8mg in 24 healthy male volunteers. The pharmacokinetics of Lornoxicam and Thiocolchicoside individually after oral administration of tablet formulation has been extensively evaluated in adult volunteers. However, no published data are available regarding the combined pharmacokinetics and bioavailability of this particular fixed dose combination. The clinical study was randomized, balanced, open-label, 2-period cross-over study. Each subject was randomized at the beginning of the study to receive either a single dose of test fixed dose combination or reference fixed dose combination during Period I. Following a 7-day wash out period, all subjects received the alternate formulation during Period II. No statistically significant differences were obtained between the two products with respect to the mean concentration-time profiles or in the pharmacokinetic parameters, including area under the serum concentration-time curve from the present study. The relative extent of absorption as assessed by the AUC ratio (Test/Reference) and C_max, the average value was found to be 1.00±0.09 with 90% confidence limits (C.L.) of 0.82-1.18. Thus, these findings clearly indicate that the two products are bioequivalent in terms of rate and extent of drug absorption. Both the preparation was well tolerated with no adverse reactions throughout the study