Bioequivalence study of single-dose lenalidomide capsule vs. Revlimid ® capsule in healthy Chinese males

Abstract

Objective

Lenalidomide is a 4-amino-glutaryl derivative of thalidomide and belongs to a new generation of immunomodulatory agents for the treatment of patients with myelodysplastic syndrome and multiple myeloma. The aim of this study is to evaluate the bioequivalence and safety of a capsule containing 25 mg of a test formulation of lenalidomide and a 25 mg Revlimid^® capsule in healthy, Chinese adult males for good quality anti-cancer medicine with lower costs.

Methods

This was a single-center, randomized, open-label, single-dose, two-period, crossover pharmacokinetic study. Forty-eight healthy, adult Chinese males were administered a test lenalidomide or Revlimid^® capsule, 24 in a fasted and 24 in a fed state, followed by crossover to the other capsule.

Results

Twenty-four subjects in the fasting group and 23 in the postprandial group completed the clinical trial. Subjects administered test lenalidomide and Revlimid^® capsules in the fasting state had a C_max of 564 ± 153 and 609 ± 121 ng/mL, respectively; an AUC_0−t of 1660 ± 211 and 1660 ± 235 h ng/mL, respectively; and an AUC_0−∞ of 1670 ± 210 and 1670 ± 237 h ng/mL, respectively. In the fed state, the subjects had a C_max of 389 ± 105 and 383 ± 101 ng/mL, respectively; an AUC_0−t of 1770 ± 314 and 1740 ± 360 h ng/mL, respectively; and an AUC_0−∞ of 1800 ± 316 and 1760 ± 362 h ng/mL, respectively. Both capsules were well tolerated, with no serious adverse events observed.

Conclusion

According to the criteria for bioequivalence, the test formulation of lenalidomide and Revlimid^® was determined to be bioequivalent.

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