Bioequivalence of HCP1104, a New Fixed Dose Combination Drug and Co-administration of Eperisone 50 mg and Aceclofenac 100 mg: A Partial Replicated Crossover Study Design to Estimate the Pharmacokinetics of Highly Variable Drugs

Background: This clinical study was conducted to compare pharmacokinetics of eperisone and aceclofenac of HCP1104, a new fixed dose combination drug with those in co-administration of eperisone 50 mg and aceclofenac 100 mg. The study used a partial replicated study design to characterize intra-subject variability of eperisone when co-administrated with aceclofenac. Methods: A partial replicated crossover design was employed in 30 subjects. Each subject received a single dose of co-administration of eperisone 50 mg and aceclofenac 100 mg on two occasions and a single dose of 1 capsule of HCP1104. Blood samples were obtained for 24 hrs after dosing, and plasma was assayed for eperisone and aceclofenac by Liquid chromatography-electrospray ionization-mass spectrometry. Results: Using an average bioequivalence criterion, the 90 % confidence limits for Ln-transformed $C_{max}$ and $AUC_{last}$ for aceclofenac fell wihin the acceptable range of 80 - 125 %. Point estimates of eperisone $AUC_{last}$ and $C_{max}$ were 1.0152 and 1.0490, respectively and the 90 % confidence interval for $C_{max}$ was 0.8499 - 1.3025. The within-subject coefficient of variation of Cmax for the reference was 50.198 %. Acceptance range for eperisone $C_{max}$ based on new bioequivalence guidance for highly variable drugs was extended to 0.6984 - 1.4319. Conclusion: The extent of exposure and rate of absorption of both eperisone and aceclofenac with a single dose of HCP1104 capsule were equivalent to those with co-administration of a marketed eperisone 50 mg tablet and a marketed aceclofenac 100 mg tablet under fasting conditions in healthy adult males.

Eperisone 50 mg과 Aceclofenac 100 mg 복합제인 HCP1104의 생물학적동등성: 부분 반복, 교차 설계 임상시험