Bioequivalency Study of Ensartinib Capsules in Healthy Volunteers

NCT03536481 | Completed Phase 1

• 1 other identifier: BTP-44315
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (8)

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

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

  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

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

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

  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

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

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

  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

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

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

  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

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

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

  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

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

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

  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

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

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

  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

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

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

  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

Secondary Outcomes (1)

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

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

Study Arms (4)

T-R cohort under fasted state

EXPERIMENTAL

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); Drug: ensartinib capsules (reference product)

R-T cohort under fasted state

EXPERIMENTAL

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); Drug: ensartinib capsules (reference product)

T-R cohort after meal

EXPERIMENTAL

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); Drug: ensartinib capsules (reference product)

R-T cohort after meal

EXPERIMENTAL

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); Drug: ensartinib capsules (reference product)

Interventions

ensartinib capsules (test product) DRUG

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

Also known as: X-396 capsules

R-T cohort after meal; R-T cohort under fasted state; T-R cohort after meal; T-R cohort under fasted state

ensartinib capsules (reference product) DRUG

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

Also known as: X-396 capsules

R-T cohort after meal; R-T cohort under fasted state; T-R cohort after meal; T-R cohort under fasted state

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Betta Pharmaceuticals Co., Ltd.: lead

Study Sites (1)

Shanghai Public Health Clinical Center

Shanghai, Shanghai Municipality, 201508, China

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

ensartinib

Condition Hierarchy (Ancestors)

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

Study Officials

• Tongyu Zhu

  Shanghai Public Health Clinical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2018
• First Posted: May 24, 2018
• Study Start: June 11, 2018
• Primary Completion: January 9, 2019
• Study Completion: January 9, 2019
• Last Updated: July 24, 2019

Record last verified: 2019-07

Locations

CN (1)