Bioequivalence assessment of two simvastatin tablets in healthy Taiwanese volunteers

Chih Meng Tseng, Chun Chen Huang, Meng Chun Ho, Yen An Chen, Ying Hua Shieh, I. Kai Chen

Research output: Contribution to journalArticle

2 Citations (Scopus)

Abstract

The pharmacokinetics and bioequivalence of two tablets of simvastatin, Zolotin and ZOCOR®, were evaluated in 26 healthy male Taiwanese volunteers who reside in Taiwan. The experiments were designed as a randomized, two-sequence, two-period and single-dose crossover study. Blood samples were obtained at 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 14 and 24 hr after oral dosing of one tablet. β-hydroxyacid simvastatin concentrations in plasma were analyzed by a validated LC/MS/MS method. The pharmacokinetic parameters were analyzed by non-compartmental analysis. The analysis of variance was carried out using log-transformed AUC0-t, AUC0-∞ and Cmax. The results revealed that the Cmax of Zolotin and ZOCOR® were 4.78 ± 2.75 ng/mL and 4.52 ± 2.01 ng/mL; the Tmax were 3.80 ± 1.63 hr and 4.31 ± 1.73 hr; the T1/2 were 4.32 ± 1.82 hr and 5.11 ± 2.49 hr; the AUC0-t were 35.6 ± 21.7 ng×hr/mL and 36.5 ± 20.0 ng×hr/ mL; and the AUC0-∞ were 38.1 ± 24.3 ng×hr/mL and 40.3 ± 23.6 ng×hr/mL, respectively. The ratios of log-transformed AUC0-t, AUC0-∞, and Cmax values of the plasma β-hydroxyacid simvastatin between two tablets were within the range of 80-125% as judged by 90% confidence intervals and satisfied the bioequivalence criteria. The generic simvastatin tablets formulation, Zolotin, was shown to be bioequivalent to the ZOCOR® tablets.

Original languageEnglish
Pages (from-to)15-19
Number of pages5
JournalJournal of Food and Drug Analysis
Volume15
Issue number1
Publication statusPublished - Mar 2007

Fingerprint

Therapeutic Equivalency
Simvastatin
Tablets
pharmacokinetics
volunteers
Healthy Volunteers
dosage
Taiwan
confidence interval
mouth
analysis of variance
Pharmacokinetics
blood
Cross-Over Studies
Volunteers
Analysis of Variance
sampling
Confidence Intervals
methodology
cross-over studies

Keywords

  • β-hydroxyacid simvastatin
  • Bioequivalence
  • Pharmacokinetics
  • Simvastatin

ASJC Scopus subject areas

  • Food Science
  • Pharmacology

Cite this

Tseng, C. M., Huang, C. C., Ho, M. C., Chen, Y. A., Shieh, Y. H., & Chen, I. K. (2007). Bioequivalence assessment of two simvastatin tablets in healthy Taiwanese volunteers. Journal of Food and Drug Analysis, 15(1), 15-19.

Bioequivalence assessment of two simvastatin tablets in healthy Taiwanese volunteers. / Tseng, Chih Meng; Huang, Chun Chen; Ho, Meng Chun; Chen, Yen An; Shieh, Ying Hua; Chen, I. Kai.

In: Journal of Food and Drug Analysis, Vol. 15, No. 1, 03.2007, p. 15-19.

Research output: Contribution to journalArticle

Tseng, CM, Huang, CC, Ho, MC, Chen, YA, Shieh, YH & Chen, IK 2007, 'Bioequivalence assessment of two simvastatin tablets in healthy Taiwanese volunteers', Journal of Food and Drug Analysis, vol. 15, no. 1, pp. 15-19.
Tseng, Chih Meng ; Huang, Chun Chen ; Ho, Meng Chun ; Chen, Yen An ; Shieh, Ying Hua ; Chen, I. Kai. / Bioequivalence assessment of two simvastatin tablets in healthy Taiwanese volunteers. In: Journal of Food and Drug Analysis. 2007 ; Vol. 15, No. 1. pp. 15-19.
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abstract = "The pharmacokinetics and bioequivalence of two tablets of simvastatin, Zolotin and ZOCOR{\circledR}, were evaluated in 26 healthy male Taiwanese volunteers who reside in Taiwan. The experiments were designed as a randomized, two-sequence, two-period and single-dose crossover study. Blood samples were obtained at 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 14 and 24 hr after oral dosing of one tablet. β-hydroxyacid simvastatin concentrations in plasma were analyzed by a validated LC/MS/MS method. The pharmacokinetic parameters were analyzed by non-compartmental analysis. The analysis of variance was carried out using log-transformed AUC0-t, AUC0-∞ and Cmax. The results revealed that the Cmax of Zolotin and ZOCOR{\circledR} were 4.78 ± 2.75 ng/mL and 4.52 ± 2.01 ng/mL; the Tmax were 3.80 ± 1.63 hr and 4.31 ± 1.73 hr; the T1/2 were 4.32 ± 1.82 hr and 5.11 ± 2.49 hr; the AUC0-t were 35.6 ± 21.7 ng×hr/mL and 36.5 ± 20.0 ng×hr/ mL; and the AUC0-∞ were 38.1 ± 24.3 ng×hr/mL and 40.3 ± 23.6 ng×hr/mL, respectively. The ratios of log-transformed AUC0-t, AUC0-∞, and Cmax values of the plasma β-hydroxyacid simvastatin between two tablets were within the range of 80-125{\%} as judged by 90{\%} confidence intervals and satisfied the bioequivalence criteria. The generic simvastatin tablets formulation, Zolotin, was shown to be bioequivalent to the ZOCOR{\circledR} tablets.",
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