2006•The Chinese Journal of Clinical PharmacologyRequires access
Bioequivalence of zopiclone tablet in Chinese healthy volunteers
Si Tian
Open publisher page 1 citations
Abstract
Objective To study the relative bioavailability, pharmacoki-netic parameters and bioequivalence of zopiclone. Methods A single oral administration of 7. 5 mg test and reference zolpiclone tablet were given to 22 healthy male volunteers in randomized crossover study respectively. HPLC fluorescent detection was used to assay the concentration of zopiclone in human serum. The data were analyzed by 3P97 program. Results The pharmacokinetic parameters after a single oral administration of 7. 5 mg test and reference products were as follows: tmax were (0.89±0.31) and (1.03 ±0.33) h;Cmax were (20.26 ±4.88) and (20. 22 ± 4. 59) ng · mL-1; AUC0-t were (118. 57 ± 24. 50) and (117.84 ±25.47) ng · h · mL-1;t1/2 were (6.58 ±2. 10) and (6.99 ±2.65) h, respectively. Variance analysis and two one -side test were performed to parameters: Cmax,AUC0-t and AUC0→∞. The relatively bio-availability of single test tablet administration was (101. 5 ± 13. 8)%. Conclusion The two preparations were of bioequivalence.