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Completed

NCT Number: NCT03536481

Bioequivalency Study of Ensartinib Capsules in Healthy Volunteers

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

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Key information

Conditions

Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Shanghai Public Health Clinical Center

Shanghai, Shanghai Municipality, 201508, China

About this study

The main objective of this study is to evaluate the bioequivalency of two preparations of ensartinib capsules in Chinese healthy volunteers under fasted state or after meal. In addition, the safety of single dose administration of ensartinib capsules 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
  • Venipuncture intolerance
  • Drug abusing in 6 months
  • Donated ≥200 mL of blood within 30 days before screening
  • Pregnant or under lactation period (female subjects)
  • Received any prescription drug, over-the-counter drug, Chinese herbal drug or vitamins in 2 weeks
  • 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

ensartinib capsules (test product)

Drug

Test product(T)：100mg ensartinib capsules manufactured by Betta Pharmaceuticals

Other names: X-396 capsules

ensartinib capsules (reference product)

Drug

Reference product(R)：100mg ensartinib capsules manufactured by Catalent Pharma Solutions

Other names: X-396 capsules

Primary outcomes

  1. Peak plasma concentration(Cmax) of ensartinib(test product) after meal

    Time frame: pre-dose(60minute),30min,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12,24,36,48,72,96,120hour

    The Cmax of ensartinib(test product) in after meal blood samples of each subject over a 120 hour period post dose

  2. Peak plasma concentration(Cmax) of ensartinib(test product) under fasted sate

    Time frame: pre-dose(60minute),30min,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12,24,36,48,72,96,120hour

    The Cmax of ensartinib(test product) in fasting blood samples of each subject over a 120 hour period post dose

  3. Peak plasma concentration(Cmax) of ensartinib(reference product) after meal

    Time frame: pre-dose(60minute),30min,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12,24,36,48,72,96,120hour

    The Cmax of ensartinib(reference product) in after meal blood samples of each subject over a 120 hour period post dose

  4. Peak plasma concentration(Cmax) of ensartinib(reference product) under fasted sate

    Time frame: pre-dose(60minute),30min,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12,24,36,48,72,96,120hour

    The Cmax of ensartinib(reference product) in fasting blood samples of each subject over a 120 hour period post dose

  5. Area under the plasma concentration versus time curve(AUC) of ensartinib(test product) after meal

    Time frame: pre-dose(60minute),30min,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12,24,36,48,72,96,120hour

    The AUC of ensartinib(test product) in after meal blood samples of each subject over a 120 hour period post dose

  6. Area under the plasma concentration versus time curve(AUC) of ensartinib(test product) under fasted sate

    Time frame: pre-dose(60minute),30min,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12,24,36,48,72,96,120hour

    The AUC of ensartinib(test product) in fasting blood samples of each subject over a 120 hour period post dose

  7. Area under the plasma concentration versus time curve(AUC) of ensartinib(reference product) after meal

    Time frame: pre-dose(60minute),30min,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12,24,36,48,72,96,120hour

    The AUC of ensartinib(reference product) in after meal blood samples of each subject over a 120 hour period post dose

  8. Area under the plasma concentration versus time curve(AUC) of ensartinib(reference product) under fasted sate

    Time frame: pre-dose(60minute),30min,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12,24,36,48,72,96,120hour

    The AUC of ensartinib(reference product) in fasting blood samples of each subject over a 120 hour period post dose

Secondary outcomes

  1. Percentage of participants with adverse events as assessed by CTCAE v4.03

    Time frame: from screening to post-study visit, assessed up to 28 days

Sponsors and collaborators

Lead sponsor

Betta Pharmaceuticals Co., Ltd.

Industry

Registry information

Official study title

Randomized,Open Label,Two-cycle,Crossover,Single Dose Bioequivalency Study of Two Preparations of Ensartinib Capsules in Healthy Chinese Volunteers Under Fasted State and After Meal

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
May 24, 2018
Registry last updated
Jul 24, 2019

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.

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