PMID- 36683548
OWN - NLM
STAT- MEDLINE
DCOM- 20230321
LR  - 20230321
IS  - 0946-1965 (Print)
IS  - 0946-1965 (Linking)
VI  - 61
IP  - 4
DP  - 2023 Apr
TI  - Pharmacokinetic and bioequivalence of lenalidomide in multiple myeloma patients.
PG  - 181-188
LID - 10.5414/CP204224 [doi]
AB  - PURPOSES: The physiological and pathological conditions of individuals could 
      influence the absorption and metabolism of drugs in vivo, so this study assessed 
      the bioequivalence and pharmacokinetics of lenalidomide 25 mg capsules (test 
      formulation) and Revlimid 25 mg capsules (reference formulation) in Chinese 
      patients with multiple myeloma (MM). MATERIALS AND METHODS: A multicenter, 
      open-label, randomized, two-period, crossover trial was established to evaluate a 
      single capsule of test and reference formulations under fasting conditions. 
      Pharmacokinetic parameters were assessed, and adverse events (AEs) were monitored 
      throughout. RESULTS: Overall, 40 patients with MM completed the study. 17 AEs 
      were reported, among which there was 1 serious event during the study. Geometric 
      ratios for the maximum plasma concentration (C(max)) (98.50%; 90% confidence 
      interval (CI), 91.89 - 105.60%), area under the plasma concentration-time curve 
      (AUC) from time 0 to the last measurable concentration (AUC((0-t))) (94.74%; CI, 
      92.07 - 97.50%), and AUC from time 0 to infinity (AUC((0-infinity))) (95.55%; CI, 
      93.07 - 98.09%) all met bioequivalence criteria. Statistics of the data of 39 
      patients after oral administration of lenalidomide (both test and reference 
      formulation) demonstrated that plasma exposure tends to increase with age. 
      CONCLUSION: The two formulations of lenalidomide 25 mg displayed similar 
      pharmacokinetic profiles and were bioequivalent. Age was verified to change the 
      pharmacokinetics of lenalidomide, as increasing age was correlated with higher 
      total exposure.
FAU - Shen, Qi
AU  - Shen Q
FAU - Gao, Tiantao
AU  - Gao T
FAU - Xiang, Jin
AU  - Xiang J
FAU - Feng, Ping
AU  - Feng P
FAU - Liu, Xinghong
AU  - Liu X
FAU - Zheng, Li
AU  - Zheng L
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PL  - Germany
TA  - Int J Clin Pharmacol Ther
JT  - International journal of clinical pharmacology and therapeutics
JID - 9423309
RN  - F0P408N6V4 (Lenalidomide)
RN  - 0 (Capsules)
RN  - 0 (Tablets)
SB  - IM
MH  - Humans
MH  - Therapeutic Equivalency
MH  - Lenalidomide/adverse effects/pharmacokinetics
MH  - Biological Availability
MH  - *Multiple Myeloma/diagnosis/drug therapy
MH  - Capsules
MH  - Area Under Curve
MH  - Administration, Oral
MH  - Cross-Over Studies
MH  - Tablets
EDAT- 2023/01/24 06:00
MHDA- 2023/03/22 06:00
CRDT- 2023/01/23 03:52
PHST- 2023/03/08 00:00 [accepted]
PHST- 2023/01/24 06:00 [pubmed]
PHST- 2023/03/22 06:00 [medline]
PHST- 2023/01/23 03:52 [entrez]
AID - 190044 [pii]
AID - 10.5414/CP204224 [doi]
PST - ppublish
SO  - Int J Clin Pharmacol Ther. 2023 Apr;61(4):181-188. doi: 10.5414/CP204224.