A Bioequivalence Study of Famitinib Malate on Healthy Chinese Volunteers

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Adult Subjects
• Intervention / Treatment: Drug: Famitinib malate

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100053
      • Xuanwu Hospital Beijing, Capital Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group TR; Intervention: Drug: famitinib malate, new formulation; Intervention: Drug: famitinib malate, old formulation.	Drug: Famitinib malate; TR group: The first period，the subjects will be administrated with Famitinib malate in new formulation, then conduct blood collection within 192h; 14 days washout；The second period，the subjects will be administrated with Famitinib malate in old formulation, then conduct blood collection within 192h. RT group: The first period，the subjects will be administrated with Famitinib malate in old formulation, then conduct blood collection within 192h; 14 days washout；The second period，the subjects will be administrated with Famitinib malate in new formulation, then conduct blood collection within 192h.
Experimental: Treatment group RT; Intervention: Drug: famitinib malate, old formulation; Intervention: Drug: famitinib malate, new formulation.	Drug: Famitinib malate; TR group: The first period，the subjects will be administrated with Famitinib malate in new formulation, then conduct blood collection within 192h; 14 days washout；The second period，the subjects will be administrated with Famitinib malate in old formulation, then conduct blood collection within 192h. RT group: The first period，the subjects will be administrated with Famitinib malate in old formulation, then conduct blood collection within 192h; 14 days washout；The second period，the subjects will be administrated with Famitinib malate in new formulation, then conduct blood collection within 192h.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics parameter: Cmax	Peak plasma concentration （Cmax）	through study completion, an average of 30 days
Pharmacokinetics parameter: AUC	Area under the plasma concentration versus time curve（AUC）	through study completion, an average of 30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics parameter: Tmax	Time of maximum observed concentration (Tmax)	through study completion, an average of 30 days
Pharmacokinetics parameter: t1/2	Half time (t1/2)	through study completion, an average of 30 days
Pharmacokinetics parameter: λz	First order elimination rate constant (λz)	through study completion, an average of 30 days
The number of participants with treatment-related adverse events assessed by CTCAE V5.0	An adverse event is any untoward medical occurrence in the subjects or clinical study participants.	through study completion, an average of 30 days

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): May 27, 2020
• Primary Completion (Actual): July 18, 2020
• Study Completion (Actual): July 18, 2020

Study Registration Dates

• First Submitted: May 19, 2020
• First Submitted That Met QC Criteria: May 19, 2020
• First Posted (Actual): May 22, 2020

Study Record Updates

• Last Update Posted (Actual): October 22, 2021
• Last Update Submitted That Met QC Criteria: October 19, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Bioequivalence; New formulation; Old formulation
• Other Study ID Numbers: FMTN-I-103

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No