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Bioequivalency Study of Ensartinib Capsules in Healthy Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03536481
Recruitment Status : Completed
First Posted : May 24, 2018
Last Update Posted : July 24, 2019
Sponsor:
Information provided by (Responsible Party):
Betta Pharmaceuticals Co., Ltd.

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

Condition or disease Intervention/treatment Phase
Lung Cancer Drug: ensartinib capsules (test product) Drug: ensartinib capsules (reference product) Phase 1

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : June 11, 2018
Actual Primary Completion Date : January 9, 2019
Actual Study Completion Date : January 9, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: T-R cohort under fasted state
Subjects will be administered with one single dose of ensartinib capsules (test product) under fasted state, after a wash period of 14 days,the subjects will be administered with one single dose of ensartinib capsules (reference product) under fasted state.
Drug: ensartinib capsules (test product)
Test product(T):100mg ensartinib capsules manufactured by Betta Pharmaceuticals
Other Name: X-396 capsules

Drug: ensartinib capsules (reference product)
Reference product(R):100mg ensartinib capsules manufactured by Catalent Pharma Solutions
Other Name: X-396 capsules

Experimental: R-T cohort under fasted state
Subjects will be administered with one single dose of ensartinib capsules (reference product) under fasted state, after a wash period of 14 days,the subjects will be administered with one single dose of ensartinib capsules (test product) under fasted state.
Drug: ensartinib capsules (test product)
Test product(T):100mg ensartinib capsules manufactured by Betta Pharmaceuticals
Other Name: X-396 capsules

Drug: ensartinib capsules (reference product)
Reference product(R):100mg ensartinib capsules manufactured by Catalent Pharma Solutions
Other Name: X-396 capsules

Experimental: T-R cohort after meal
Subjects will be administered with one single dose of ensartinib capsules (test product) after meal, after a wash period of 14 days,the subjects will be administered with one single dose of ensartinib capsules (reference product) after meal.
Drug: ensartinib capsules (test product)
Test product(T):100mg ensartinib capsules manufactured by Betta Pharmaceuticals
Other Name: X-396 capsules

Drug: ensartinib capsules (reference product)
Reference product(R):100mg ensartinib capsules manufactured by Catalent Pharma Solutions
Other Name: X-396 capsules

Experimental: R-T cohort after meal
Subjects will be administered with one single dose of ensartinib capsules (reference product) after meal, after a wash period of 14 days,the subjects will be administered with one single dose of ensartinib capsules (test product) after meal.
Drug: ensartinib capsules (test product)
Test product(T):100mg ensartinib capsules manufactured by Betta Pharmaceuticals
Other Name: X-396 capsules

Drug: ensartinib capsules (reference product)
Reference product(R):100mg ensartinib capsules manufactured by Catalent Pharma Solutions
Other Name: X-396 capsules




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03536481


Locations
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China, Shanghai
Shanghai Public Health Clinical Center
Shanghai, Shanghai, China, 201508
Sponsors and Collaborators
Betta Pharmaceuticals Co., Ltd.
Investigators
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Principal Investigator: Tongyu Zhu Shanghai Public Health Clinical Center
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Responsible Party: Betta Pharmaceuticals Co., Ltd.
ClinicalTrials.gov Identifier: NCT03536481    
Other Study ID Numbers: BTP-44315
First Posted: May 24, 2018    Key Record Dates
Last Update Posted: July 24, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ensartinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action