A Bioequivalence Study of Famitinib Malate on Healthy Chinese Volunteers

NCT04400123 | Completed Phase 1

• 1 other identifier: FMTN-I-103
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Adult Subjects

Keywords

Bioequivalence; Old formulation; New formulation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Pharmacokinetics parameter: Tmax

  through study completion, an average of 30 days

• Pharmacokinetics parameter: t1/2

  through study completion, an average of 30 days

• Pharmacokinetics parameter: λz

  through study completion, an average of 30 days

• The number of participants with treatment-related adverse events assessed by CTCAE V5.0

  through study completion, an average of 30 days

Study Arms (2)

Treatment group TR

EXPERIMENTAL

Intervention: Drug: famitinib malate, new formulation; Intervention: Drug: famitinib malate, old formulation.

Drug: Famitinib malate

Treatment group RT

EXPERIMENTAL

Intervention: Drug: famitinib malate, old formulation; Intervention: Drug: famitinib malate, new formulation.

Drug: Famitinib malate

Interventions

Famitinib malate DRUG

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.

Treatment group RT; Treatment group TR

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male subjects aged 18\~45 (including 18 and 45 years old);
• 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));
• Consent to abstinence or take effective non-drug contraception measures during the study and for at least 3 months after the last drug administration.
• 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;

You may not qualify if:

• 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.
• Those who have undergone surgery within 6 months before the trial, or plan to perform surgery during the study period;
• Those who donated blood or suffered heavy blood loss (≥200 mL), received blood transfusions, or used blood products within 3 months before enrollment;
• Have a history of allergies to drugs, food or other substances;
• Have taken sedatives, sleeping pills or other addictive medicines within 1 year before the study; Those with positive results in urine drug abuse screening;
• Those who have participated in any clinical trials and have taken study drugs within 3 months before the first administration;
• 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);
• 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;
• 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;
• 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;
• 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;
• 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;
• Other factors of the subject that are not suitable for participating in the study judged by the investigators.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Xuanwu Hospital Beijing, Capital Medical University

Beijing, Beijing Municipality, 100053, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 19, 2020
• First Posted: May 22, 2020
• Study Start: May 27, 2020
• Primary Completion: July 18, 2020
• Study Completion: July 18, 2020
• Last Updated: October 22, 2021

Record last verified: 2021-10

Locations

CN (1)