Clinical trial NCT04400123: A Bioequivalence Study of Famitinib Malate on Healthy Chinese Volunteers
Official title: A Single-centre, Single-dose, Randomized, Open-label and Two-cycle Crossover Bioequivalence Study of Famitinib Malate Capsules in Old and New Formulation on Healthy Chinese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Adult Subjects
Keywords: Bioequivalence
Old formulation
New formulation
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-05-22
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Treatment group TR Intervention: Drug: famitinib malate, new formulation; Intervention: Drug: famitinib malate, old formulation.

Treatment group RT Intervention: Drug: famitinib malate, old formulation; Intervention: Drug: famitinib malate, new formulation.
Primary purpose: BASIC_SCIENCE

Brief summary: The primary objective is to evaluate the bioequivalence of famitinib malate capsules in new and old formulations after oral dose under fasted condition on healthy Chinese subjects.

The secondary objective is to evaluate the safety after famitinib malate capsules oral dose on healthy Chinese subjects.


Eligibility criteria: Inclusion Criteria:

1. Healthy male subjects aged 18\~45 (including 18 and 45 years old);
2. Body weight ≥ 50kg, body mass index (BMI) within the range of 19 \~ 26kg/m2 (including 19 and 26 kg/m2) (BMI= weight (kg)/height 2 (m2));
3. Consent to abstinence or take effective non-drug contraception measures during the study and for at least 3 months after the last drug administration.
4. The subjects were able to communicate well with the researchers, understand and comply with the requirements of this study, understand and sign the informed consent;

Exclusion Criteria:

1. Anyone who has suffered from any clinical serious disease such as the circulatory system, endocrine system, nervous system, digestive system, respiratory system, urogenital system, hematology, immunology, psychiatry and metabolic abnormalities, or any other disease which can affect the study results.
2. Those who have undergone surgery within 6 months before the trial, or plan to perform surgery during the study period;
3. Those who donated blood or suffered heavy blood loss (≥200 mL), received blood transfusions, or used blood products within 3 months before enrollment;
4. Have a history of allergies to drugs, food or other substances;
5. Have taken sedatives, sleeping pills or other addictive medicines within 1 year before the study; Those with positive results in urine drug abuse screening;
6. Those who have participated in any clinical trials and have taken study drugs within 3 months before the first administration;
7. Those who have taken any medicine within 4 weeks before the first administration (including prescription medicines, non-prescription medicines, Chinese herbal medicines, vitamins, calcium tablets and other food supplements);
8. Those who smoked more than 5 cigarettes per day within 3 months before the study and who could not stop using any tobacco products during the study;
9. Regular drinkers within 6 months before the test, that is, drinking more than 14 units of alcohol per week (1 unit = 285 mL of beer, or 25 mL of spirits, or 100 mL of wine), and any alcohol-containing products cannot be stopped during the study Those who are positive for alcohol breath test;
10. Those with any abnormal result (clinically significant) of vital signs, physical examination, 12-lead electrocardiogram, chest radiograph, abdominal ultrasound, colour Doppler echocardiography, hematology, clinical chemistry, urinalysis and coagulation;
11. Hepatitis B virus surface antigen is positive, or hepatitis C virus antibody is positive, or treponema pallidum antibody is positive, or human immunodeficiency virus antibody is positive;
12. The subject refuses to stop any beverage or food containing methylxanthine, such as coffee, tea, cola, chocolate, etc., within 48 hours before the first dose until the end of the study; The subject refuses to stop any beverage or food containing grapefruit; Those who have special dietary requirements and cannot accept the unified diet;
13. Other factors of the subject that are not suitable for participating in the study judged by the investigators.

Primary outcomes:
measure: Pharmacokinetics parameter: Cmax
timeFrame: through study completion, an average of 30 days
measure: Pharmacokinetics parameter: AUC
timeFrame: through study completion, an average of 30 days
Secondary outcomes:
measure: Pharmacokinetics parameter: Tmax
timeFrame: through study completion, an average of 30 days
measure: Pharmacokinetics parameter: t1/2
timeFrame: through study completion, an average of 30 days
measure: Pharmacokinetics parameter: λz
timeFrame: through study completion, an average of 30 days
measure: The number of participants with treatment-related adverse events assessed by CTCAE V5.0
timeFrame: through study completion, an average of 30 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital Beijing, Capital Medical University
state: Beijing
Study officials:
References: