Healthy Adult SubjectsPhase 1NCT04400123
A Bioequivalence Study of Famitinib Malate on Healthy Chinese Volunteers
A Phase 1 study testing Famitinib malate in people with Healthy Adult Subjects, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Subjects
- What is being tested?
- Famitinib malate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 27 May 2020to 18 Jul 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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;
Who cannot join
- 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;
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Xuanwu Hospital Beijing, Capital Medical University
Beijing, Beijing Municipality, 100053
About this study
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
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
- Being tested
- Famitinib malate
- Keywords
- Bioequivalence, Old formulation, New formulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Famitinib malateDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group TR | Experimental | Intervention: Drug: famitinib malate, new formulation; Intervention: Drug: famitinib malate, old formulation. Receives: Drug: Famitinib malate |
| Treatment group RT | Experimental | Intervention: Drug: famitinib malate, old formulation; Intervention: Drug: famitinib malate, new formulation. Receives: Drug: Famitinib malate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics parameter: Cmax
Peak plasma concentration （Cmax）
Measured: through study completion, an average of 30 days
Pharmacokinetics parameter: AUC
Area under the plasma concentration versus time curve（AUC）
Measured: through study completion, an average of 30 days
Secondary outcomes (4)
Pharmacokinetics parameter: Tmax
Time of maximum observed concentration (Tmax)
Measured: through study completion, an average of 30 days
Pharmacokinetics parameter: t1/2
Half time (t1/2)
Measured: through study completion, an average of 30 days
Pharmacokinetics parameter: λz
First order elimination rate constant (λz)
Measured: 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.
Measured: through study completion, an average of 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2020
- Study start27 May 2020
- Primary completion18 Jul 2020
- Study completion18 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult SubjectsStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04400123
- Sponsor's protocol ID
- FMTN-I-103
- Status last verified
- Oct 2021
- First submitted
- 19 May 2020
- Last updated
- 22 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04400123
- Acronym / sponsor ID
- FMTN-I-103
- Conditions
- Healthy Adult Subjects
- Keywords
- Bioequivalence, Old formulation, New formulation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 27 May 2020 (actual)
- Primary completion
- 18 Jul 2020 (actual)
- Study completion
- 18 Jul 2020 (actual)
- First posted
- 22 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Treatment group TR | Experimental | Drug: Famitinib malateIntervention: Drug: famitinib malate, new formulation; Intervention: Drug: famitinib malate, old formulation. |
| Treatment group RT | Experimental | Drug: Famitinib malateIntervention: Drug: famitinib malate, old formulation; Intervention: Drug: famitinib malate, new formulation. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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;
Key exclusion criteria (13 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Famitinib malateTR 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. | Drug | Treatment group RT, Treatment group TR |
Primary outcome
Pharmacokinetics parameter: Cmax
Time frame: through study completion, an average of 30 days
Peak plasma concentration （Cmax）
Pharmacokinetics parameter: AUC
Time frame: through study completion, an average of 30 days
Area under the plasma concentration versus time curve（AUC）
4 secondary outcomes
Pharmacokinetics parameter: Tmax
Time frame: through study completion, an average of 30 days
Pharmacokinetics parameter: t1/2
Time frame: through study completion, an average of 30 days
Pharmacokinetics parameter: λz
Time frame: through study completion, an average of 30 days
The number of participants with treatment-related adverse events assessed by CTCAE V5.0
Time frame: through study completion, an average of 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2021.
- Individual participant dataSharing planned: Undecided
Related trials for Healthy Adult Subjects
Not yet recruiting
Acute Effects of High-Intensity Laser Therapy on Pain, Muscle Stiffness, and Grip Strength in Healthy Adults
Exercise-Induced Muscle Fatigue, Fatigue Recovery
RecruitingPhase 1
PET Imaging of the sigma1 Receptor in Healthy Adults
Healthy Control Subjects
RecruitingPhase 1
Phase Ia Study of MST-931 in Healthy Adult Subjects
Ankylosing Spondylitis (AS)
Active, not recruitingPhase 3
A Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 With Influenza Vaccine in Adults ≥ 50 Years of Age
Pneumococcal Disease
RecruitingPhase 1
A Single Ascending Dose, and Food Effect Study of ABBV-7828 in Healthy Adults
Healthy Subjects
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Famitinib malate in people with Healthy Adult Subjects, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics parameter: Cmax (time frame: through study completion, an average of 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2021.