Bioequivalency Study of CM082 Tablet in Healthy Volunteers

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.

Study Overview

• Status: Completed
• Conditions: Advanced Malignant Solid Tumors
• Intervention / Treatment: Drug: CM082 tablet (test product); Drug: CM082 tablet (reference product)

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 Type: Interventional
• Enrollment (Actual): 96
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 311009
      • The 1st Phase Clinical Research Center of the Second Affiliated Hospital of Zhejiang University Medical College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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
• 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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: T-R cohort under fasted state; 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.	Drug: CM082 tablet (test product); Test product(T)：100mg CM082 tablet manufactured by Betta Pharmaceuticals; Drug: CM082 tablet (reference product); Reference product(R)：100mg CM082 tablet manufactured by Catalent Pharma Solutions
Experimental: R-T cohort under fasted state; 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.	Drug: CM082 tablet (test product); Test product(T)：100mg CM082 tablet manufactured by Betta Pharmaceuticals; Drug: CM082 tablet (reference product); Reference product(R)：100mg CM082 tablet manufactured by Catalent Pharma Solutions
Experimental: T-R cohort after meal; 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.	Drug: CM082 tablet (test product); Test product(T)：100mg CM082 tablet manufactured by Betta Pharmaceuticals; Drug: CM082 tablet (reference product); Reference product(R)：100mg CM082 tablet manufactured by Catalent Pharma Solutions
Experimental: R-T cohort after meal; 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	Drug: CM082 tablet (test product); Test product(T)：100mg CM082 tablet manufactured by Betta Pharmaceuticals; Drug: CM082 tablet (reference product); Reference product(R)：100mg CM082 tablet manufactured by Catalent Pharma Solutions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of adverse events	Percentage of adverse events as assessed by CTCAE v4.03	From the first occurrence of adverse events after administration to the cessation of adverse events, assessed up to 2 months

Collaborators and Investigators

• Sponsor: AnewPharma
• Investigators: Study Chair: zourong ruan, The Second Affiliated Hospital of Zhejiang University Medical College

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2020
• Primary Completion (Actual): July 27, 2020
• Study Completion (Actual): July 27, 2020

Study Registration Dates

• First Submitted: March 26, 2020
• First Submitted That Met QC Criteria: March 30, 2020
• First Posted (Actual): March 31, 2020

Study Record Updates

• Last Update Posted (Actual): November 26, 2021
• Last Update Submitted That Met QC Criteria: November 24, 2021
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protein Kinase Inhibitors; Vorolanib
• Other Study ID Numbers: CM082-CA-I-108

Drug and device information, study documents

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