臨床研究等提出・公開システム

Bioequivalence study of FSK1924-2

BE study of FSK1924-2

30

In total, 30 healthy Japanese menopausal female subjects were randomized, and all subjects received the study drug. Among the subjects who were administered the study drug, 25 subjects completed the study and were included in Pharmacokinetic analysis. The mean age (SD) was 57.8 (3.42) years, the mean BMI (SD) was 22.05 (2.189) kg/m2, and the mean body weight (SD) was 54.82 (6.974) kg.

All 30 subjects who consented to participate in the study were randomly assigned to either FSK1924-2 or Revlimid capsules treatment groups in a 1:1 ratio.

For adverse events, three subjects (11.1%) out of the 27 subjects in the FSK1924-2 treatment group experienced three adverse events. Meanwhile, six subjects (21.4%) out of the 28 subjects in the Revlimid capsules treatment group experienced nine adverse events. All of the adverse events that occurred were non-serious and mild in severity. For adverse drug reactions, one subject (3.7%) in the FSK1924-2 treatment group experienced "stomatitis" (1 event) while two subjects (7.1%) in the Revlimid capsules treatment group experienced "surfactant protein increased" (2 events) and three subjects (10.7%) experienced "muscle spasms" (3 events). Based on these observations, it can be concluded that FSK1924-2 and Revlimid capsules have comparable safety profiles.

Lenalidomide was rapidly absorbed after administration of the FSK1924-2 and Revlimid capsule, and the highest plasma concentration of Lenalidomide was observed at 0.5 hours after taking the FSK1924-2 and at 0.75 hours after taking the Revlimid capsules. After that, the levels gradually decreased and were below detectable limits after 24 hours of taking the study drug. Based on the statistical analysis of the parameters AUCt and Cmax, which evaluate the bioequivalence of plasma lenalidomide concentrations for both drugs, the mean values of the logarithmic differences between the drugs were log(1.0007) and log(1.0133), respectively. The mean differences between the drugs are presented as the two-sided 90% confidence intervals of the logs: log(0.9836) to log(1.0182) and log(0.9369) to log(1.0959). Both intervals met the criteria for bioequivalence, falling within the range of log(0.80) to log(1.25).

The bioequivalence of plasma lenalidomide concentrations for both drugs was evaluated using parameters such as AUCt and Cmax. The mean values of the logs between the drugs were compared using two-sided 90% confidence intervals. These intervals were found to conform to the criteria for bioequivalence, which range from log(0.80) to log(1.25). Based on the results of the study, the FSK1924-2 and Revlimid capsules were considered to be bioequivalent.

Dec. 08, 2023

No

https://jrct.mhlw.go.jp/latest-detail/jRCT2031210413

Arai Fumiko

Fuji Pharma Co., Ltd.

5-7 Sanban-cho, Chiyoda-ku, Tokyo

clinical_trials@fujipharma.jp

Arai Fumiko

Fuji Pharma Co., Ltd.

5-7 Sanban-cho, Chiyoda-ku, Tokyo

+81-3-3556-3344

clinical_trials@fujipharma.jp

Complete

Nov. 08, 2021

Interventional

randomized controlled trial

open(masking not used)

no treatment control/standard of care control

crossover assignment

other

(1) Those who have fully understood the contents of this clinical trial and have given their written informed consent to participate in the clinical trial.
(2) Those who are able to comply with the requirements during the clinical trial, undergo medical examinations and tests specified in the method of the clinical trial, and are able to report subjective symptoms, etc.
(3) Women who are 45 years old or older, and under 65 years old at the time of giving their consent.
(4) Naturally postmenopausal women who have no menstruation for a year or longer at the time of giving their consent.
(5) Those who weigh 40 kg or more at the time of screening and have a body mass index of 18.8 or more and less than 26.4. (check at the time of screening)

(1)Those who have been diagnosed by a principal investigator or others with complications or abnormalities in hematopoiesis, cardiovascular system, liver, kidney, respiratory system, digestive system, reproductive system, or hormone (endocrine) system (including those prescribed with long-term bed rest, and those with dehydration, heart failure, diabetes, hyperlipidemia, hypertension, and hyperuricemia). In addition, those who have a medical history where the aforementioned organ(s) were not deemed to be medically healthy.
(2)Those who are allergic to the main components or additives of the study drug, those who have a medical history of allergies or current allergy symptoms to drugs, as well as those who have clinically apparent allergic diseases (excluding those who have pollinosis but currently exhibit no symptoms).
(3)Those whose serum estradiol levels are 20 pg/mL or more at the time of screening.
(4)Those who have tested positive on their pregnancy tests at the time of screening as well as on the day before the start of administration.
(5)Those whose clinical laboratory test values at the time of screening as well as on the day before the start of administration deviated from the institutions reference range.
1)Blood coagulation tests (FDP, D-dimer, APTT)
2)Hematological tests (white blood cell count, neutrophil count, hemoglobin count, platelet count)
3)Pulmonary fibrosis biomarkers (KL-6, SP-A, SP-D)
4)Renal function tests (BUN, creatinine)
(6)Those with abnormal chest X-rays
(7)Those with SpO2 values that deviated from the institutions reference range
(8)Those who have a medical history of interstitial lung disease
(9)Those who are suspected, or have a history of thromboembolism, those whose PT-INR of less than 0.85
(10)Those who regularly drink excessive alcohol (60 g or more of pure alcohol per day)
(11)Those who smoke (excluding those who are able to abstain from smoking for the period specified in this clinical trial protocol).
(12)Those who have difficulty swallowing capsules.
(13)Those who have participated in clinical trial(s) within four months (or three months for approved drug products), or have undergone patch testing within a month, and were administered with this study drug prior to participating in this clinical trial. However, for those who have participated in clinical trial(s) involving the sustained-release version, they should be subjected to a final observation within four months before being administered with this study drug. In addition, this does not apply to those who participated in the clinical trial(s) but were not administered with the drug(s).
(14)Those who have used other drugs (including other health or dietary supplements) within a week before screening.
(15)Those from whom blood volume of more than 200 mL within four weeks, 400 mL within 16 weeks, and 800 mL within a year, have been collected before drug administration. Or those who have undergone apheresis within two weeks before screening
(16)Those who tested positive for hepatitis B, hepatitis C, syphilis, or HIV. For hepatitis B, those who are hepatitis B virus carrier or have previous infections (HBs Ag negative and HBc antibody or HBs antibody positive)
(17)Those with suspected infectious diseases such as fever and sore throat
(18)Those who tested positive in urine drug tests (phencyclidines, benzodiazepines, cocaine, amphetamines, cannabis, morphine-like narcotics, barbiturates, tricyclic antidepressants, methylenedioxymethamphetamines, oxycodones, propoxyphenes)
(19)Those who have been deemed by the principal investigator or others to be ineligible to participate in this clinical trial

Female

multiple myeloma, myelodysplastic syndromes with chromosome 5q deletion syndrome

FSK1924-2 or Revlimid cap 5mg administered orally

Area under the plasma concentration-time curve up to time (AUCt), maximum plasma concentration (Cmax)

+81-3-5800-8743

Sept. 13, 2021

none