Bioequivalency Study of CM082 Tablet in Healthy Volunteers

NCT ID: NCT04328506

Last Updated: 2021-11-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-01
• Study Completion Date: 2020-07-27

Brief Summary

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.

Conditions

Advanced Malignant Solid Tumors

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

CM082 tablet (test product)

Intervention Type: DRUG

Test product(T)：100mg CM082 tablet manufactured by Betta Pharmaceuticals

CM082 tablet (reference product)

Intervention Type: DRUG

Reference product(R)：100mg CM082 tablet manufactured by Catalent Pharma Solutions

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.

Group Type: EXPERIMENTAL

CM082 tablet (test product)

Intervention Type: DRUG

Test product(T)：100mg CM082 tablet manufactured by Betta Pharmaceuticals

CM082 tablet (reference product)

Intervention Type: DRUG

Reference product(R)：100mg CM082 tablet manufactured by Catalent Pharma Solutions

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.

Group Type: EXPERIMENTAL

CM082 tablet (test product)

Intervention Type: DRUG

Test product(T)：100mg CM082 tablet manufactured by Betta Pharmaceuticals

CM082 tablet (reference product)

Intervention Type: DRUG

Reference product(R)：100mg CM082 tablet manufactured by Catalent Pharma Solutions

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

Group Type: EXPERIMENTAL

CM082 tablet (test product)

Intervention Type: DRUG

Test product(T)：100mg CM082 tablet manufactured by Betta Pharmaceuticals

CM082 tablet (reference product)

Intervention Type: DRUG

Reference product(R)：100mg CM082 tablet manufactured by Catalent Pharma Solutions

Interventions

CM082 tablet (test product)

Test product(T)：100mg CM082 tablet manufactured by Betta Pharmaceuticals

Intervention Type: DRUG

CM082 tablet (reference product)

Reference product(R)：100mg CM082 tablet manufactured by Catalent Pharma Solutions

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

AnewPharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

zourong ruan

Role: STUDY_CHAIR

the Second Affiliated Hospital of Zhejiang University Medical College

Locations

The 1st Phase Clinical Research Center of the Second Affiliated Hospital of Zhejiang University Medical College

Hangzhou, Zhejiang, China

Countries

China

Other Identifiers

CM082-CA-I-108

Identifier Type: -

Identifier Source: org_study_id