Skip to main content
OpenTrials
Completed

NCT Number: NCT04328506

Bioequivalency Study of CM082 Tablet in Healthy Volunteers

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Advanced Malignant Solid Tumors

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

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

Hangzhou, Zhejiang, 311009, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. 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

  2. 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

  3. 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

Secondary outcomes

  1. 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

    Percentage of adverse events as assessed by CTCAE v4.03

Sponsors and collaborators

Lead sponsor

AnewPharma

Industry

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Mar 31, 2020
Registry last updated
Nov 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.