Bioequivalency Study of CM082 Tablet in Healthy Volunteers

Advanced Malignant Solid Tumors Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04328506
• Other study ID #: CM082-CA-I-108
• Status: Completed
• Phase: Phase 1
• Start date: June 1, 2020
• Est. completion date: July 27, 2020

Study information

• Verified date: March 2020
• Source: AnewPharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main objective of this study is to evaluate the bioequivalency of two preparations of CM082 tablet in Chinese healthy volunteers.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: July 27, 2020
• Est. primary completion date: July 27, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Advanced Malignant Solid Tumors

Intervention

Drug:
• CM082 tablet (test product)
Test product(T):100mg CM082 tablet manufactured by Betta Pharmaceuticals
• CM082 tablet (reference product)
Reference product(R):100mg CM082 tablet manufactured by Catalent Pharma Solutions

Locations

Country	Name	City	State
China	The 1st Phase Clinical Research Center of the Second Affiliated Hospital of Zhejiang University Medical College	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
AnewPharma

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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]
Primary	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]
Primary	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	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