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.
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