Advanced Malignant Solid TumorsPhase 1NCT04328506
Bioequivalency Study of CM082 Tablet in Healthy Volunteers
A Phase 1 study testing CM082 tablet (test product) and CM082 tablet (reference product) in people with Advanced Malignant Solid Tumors, run by AnewPharma at 1 site in China.
Trial summary
The main objective of this study is to evaluate the bioequivalency of two preparations of CM082 tablet in Chinese healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Advanced Malignant Solid Tumors
- What is being tested?
- CM082 tablet (test product) and CM082 tablet (reference product)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2020to 27 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male body weight≥50.0kg or female body weight≥45.0kg; BMI between 19.0-26.0 kg/m2(inclusive)
- Generally in good health, with no history of chronic disease or sever disease
- No (clinical significant) abnormal findings in clinical laboratory tests and physical examinations
- No plan for pregnancy in coming 6 months, and must practice effective contraception; No plan for sperm or egg donation
- Written informed consent
Who cannot join
- History of food or drug allergies
- Clinical significant disease or disorders
- Received surgery in 3 months before screening, or have plan for surgery during the study
- Participated in other clinical trials within 3 months before screening
- Intolerant of venipuncture, history of fainting needle and blood
- Lactose intolerant
Show all 13Show fewer
- Drug abusing in 3 months
- Donated ≥200 mL of blood within 3 months before screening
- Pregnant or under lactation period (female subjects)
- Received any prescription drug, over-the-counter drug, prescription drug and Chinese herbal drug in 2 weeks, with the exception of vitamins and acetaminophen
- Received any vaccine in 4 weeks
- Excessively smoking, alcohol or coffin-containing beverage drinking in 3 months
- Other circumstances that is deemed not appropriate for the study
Trial locations and contacts
1 site in 1 country.
China1 site
The 1st Phase Clinical Research Center of the Second Affiliated Hospital of Zhejiang University Medical College
Hangzhou, Zhejiang, 311009
About this study
Official title: Randomized,Open Label,Two-cycle,Crossover,Single Dose Bioequivalency Study of Two Preparations of CM082 Tablet in Healthy Chinese Volunteers Under Fasted State and After Meal
The main objective of this study is to evaluate the bioequivalency of two preparations of CM082 tablet in Chinese healthy volunteers.
Read the detailed description
The main objective of this study is to evaluate the bioequivalency of two preparations of CM082 tablet in Chinese healthy volunteers under fasted state or after meal. In addition, the safety of single dose administration of CM082 tablet in Chinese healthy volunteers will also be evaluated.
- Conditions
- Advanced Malignant Solid Tumors
- Being tested
- CM082 tablet (test product), CM082 tablet (reference product)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CM082 tablet (test product)Drug
Test product(T)：100mg CM082 tablet manufactured by Betta Pharmaceuticals
CM082 tablet (reference product)Drug
Reference product(R)：100mg CM082 tablet manufactured by Catalent Pharma Solutions
| Study group | Role | What they receive |
|---|---|---|
| T-R cohort under fasted state | Experimental | Subjects will be administered with one single dose of CM082 tablet (test product) under fasted state, after a wash period of 5 days, the subjects will be administered with one single dose of CM082 tablet (reference product) under fasted state. Receives: Drug: CM082 tablet (test product); Drug: CM082 tablet (reference product) |
| R-T cohort under fasted state | Experimental | Subjects will be administered with one single dose of CM082 tablet (reference product) under fasted state, after a wash period of 5 days,the subjects will be administered with one single dose of CM082 tablet (test product) under fasted state. Receives: Drug: CM082 tablet (test product); Drug: CM082 tablet (reference product) |
| T-R cohort after meal | Experimental | Subjects will be administered with one single dose of CM082 tablet (test product) after meal, after a wash period of 5 days,the subjects will be administered with one single dose of CM082 tablet (reference product) after meal. Receives: Drug: CM082 tablet (test product); Drug: CM082 tablet (reference product) |
| R-T cohort after meal | Experimental | Subjects will be administered with one single dose of CM082 tablet (reference product) after meal, after a wash period of 14 days,the subjects will be administered with one single dose of CM082 tablet (test product) after meal Receives: Drug: CM082 tablet (test product); Drug: CM082 tablet (reference product) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak plasma concentration(Cmax) of CM082 (test product or reference product) under fasted state or after meal
The Cmax ofCM082 (test product or reference product) in under fasted state or after meal blood samples of each subject over a 72 hour period post dose
Measured: pre-dose(30minute),30min,1,1.5,2,2.5,3,3.5,4,4.5,5,6,7,8,10,12,16,24,36,48,72 hour]
Area under the plasma concentration versus time curve(AUC) of CM082 (test product or reference product) under fasted state or after meal
The AUC of CM082 (test product or reference product) in under fasted state or after meal blood samples of each subject over a 72 hour period post dose
Measured: pre-dose(30minute),30min,1,1.5,2,2.5,3,3.5,4,4.5,5,6,7,8,10,12,16,24,36,48,72 hour]
Time of maximum concentration (Tmax) of CM082 (test product or reference product) under fasted state or after meal
The Tmax of CM082 (test product or reference product) in under fasted state or after meal blood samples of each subject over a 72 hour period post dose
Measured: pre-dose(30minute),30min,1,1.5,2,2.5,3,3.5,4,4.5,5,6,7,8,10,12,16,24,36,48,72 hour]
Secondary outcomes (1)
Percentage of adverse events
Percentage of adverse events as assessed by CTCAE v4.03
Measured: From the first occurrence of adverse events after administration to the cessation of adverse events, assessed up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2020
- Study start1 Jun 2020
- Primary completion27 Jul 2020
- Study completion27 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Malignant Solid TumorsStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- AnewPharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- zourong ruan, Study chair, the Second Affiliated Hospital of Zhejiang University Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04328506
- Sponsor's protocol ID
- CM082-CA-I-108
- Status last verified
- Mar 2020
- First submitted
- 26 Mar 2020
- Last updated
- 26 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized,Open Label,Two-cycle,Crossover,Single Dose Bioequivalency Study of Two Preparations of CM082 Tablet in Healthy Chinese Volunteers Under Fasted State and After Meal
- ClinicalTrials.gov ID
- NCT04328506
- Acronym / sponsor ID
- CM082-CA-I-108
- Conditions
- Advanced Malignant Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- AnewPharmaIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 27 Jul 2020 (actual)
- Study completion
- 27 Jul 2020 (actual)
- First posted
- 31 Mar 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 main objective of this study is to evaluate the bioequivalency of two preparations of CM082 tablet in Chinese healthy volunteers.
Detailed description
The main objective of this study is to evaluate the bioequivalency of two preparations of CM082 tablet in Chinese healthy volunteers under fasted state or after meal. In addition, the safety of single dose administration of CM082 tablet in Chinese healthy volunteers will also be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| T-R cohort under fasted state | Experimental | Drug: CM082 tablet (test product), Drug: CM082 tablet (reference product)Subjects will be administered with one single dose of CM082 tablet (test product) under fasted state, after a wash period of 5 days, the subjects will be administered with one single dose of CM082 tablet (reference product) under fasted state. |
| R-T cohort under fasted state | Experimental | Drug: CM082 tablet (test product), Drug: CM082 tablet (reference product)Subjects will be administered with one single dose of CM082 tablet (reference product) under fasted state, after a wash period of 5 days,the subjects will be administered with one single dose of CM082 tablet (test product) under fasted state. |
| T-R cohort after meal | Experimental | Drug: CM082 tablet (test product), Drug: CM082 tablet (reference product)Subjects will be administered with one single dose of CM082 tablet (test product) after meal, after a wash period of 5 days,the subjects will be administered with one single dose of CM082 tablet (reference product) after meal. |
| R-T cohort after meal | Experimental | Drug: CM082 tablet (test product), Drug: CM082 tablet (reference product)Subjects will be administered with one single dose of CM082 tablet (reference product) after meal, after a wash period of 14 days,the subjects will be administered with one single dose of CM082 tablet (test product) after meal |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male body weight≥50.0kg or female body weight≥45.0kg; BMI between 19.0-26.0 kg/m2(inclusive)
- Generally in good health, with no history of chronic disease or sever disease
- No (clinical significant) abnormal findings in clinical laboratory tests and physical examinations
- No plan for pregnancy in coming 6 months, and must practice effective contraception; No plan for sperm or egg donation
- Written informed consent
Key exclusion criteria (13 listed)
- History of food or drug allergies
- Clinical significant disease or disorders
- Received surgery in 3 months before screening, or have plan for surgery during the study
- Participated in other clinical trials within 3 months before screening
- Intolerant of venipuncture, history of fainting needle and blood
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 |
|---|---|---|
| CM082 tablet (test product)Test product(T)：100mg CM082 tablet manufactured by Betta Pharmaceuticals | Drug | R-T cohort after meal, R-T cohort under fasted state, T-R cohort after meal, T-R cohort under fasted state |
| CM082 tablet (reference product)Reference product(R)：100mg CM082 tablet manufactured by Catalent Pharma Solutions | Drug | R-T cohort after meal, R-T cohort under fasted state, T-R cohort after meal, T-R cohort under fasted state |
Primary outcome
Peak plasma concentration(Cmax) of CM082 (test product or reference product) under fasted state or after meal
Time frame: pre-dose(30minute),30min,1,1.5,2,2.5,3,3.5,4,4.5,5,6,7,8,10,12,16,24,36,48,72 hour]
The Cmax ofCM082 (test product or reference product) in under fasted state or after meal blood samples of each subject over a 72 hour period post dose
Area under the plasma concentration versus time curve(AUC) of CM082 (test product or reference product) under fasted state or after meal
Time frame: pre-dose(30minute),30min,1,1.5,2,2.5,3,3.5,4,4.5,5,6,7,8,10,12,16,24,36,48,72 hour]
The AUC of CM082 (test product or reference product) in under fasted state or after meal blood samples of each subject over a 72 hour period post dose
Time of maximum concentration (Tmax) of CM082 (test product or reference product) under fasted state or after meal
Time frame: pre-dose(30minute),30min,1,1.5,2,2.5,3,3.5,4,4.5,5,6,7,8,10,12,16,24,36,48,72 hour]
The Tmax of CM082 (test product or reference product) in under fasted state or after meal blood samples of each subject over a 72 hour period post dose
1 secondary outcome
Percentage of adverse events
Time frame: From the first occurrence of adverse events after administration to the cessation of adverse events, assessed up to 2 months
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 26 Nov 2021.
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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.
zourong ruan study chair
the Second Affiliated Hospital of Zhejiang University Medical College
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 CM082 tablet (test product) and CM082 tablet (reference product) in people with Advanced Malignant Solid Tumors, run by AnewPharma 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 5 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 26 Nov 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?
Peak plasma concentration(Cmax) of CM082 (test product or reference product) under fasted state or after meal (time frame: pre-dose(30minute),30min,1,1.5,2,2.5,3,3.5,4,4.5,5,6,7,8,10,12,16,24,36,48,72 hour]). The study lists 3 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 26 Nov 2021.