Bioequivalency Study of Ensartinib Capsules in Healthy Volunteers

Betta Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Lung Cancer

Treatments: Drug: ensartinib capsules (test product); Drug: ensartinib capsules (reference product)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03536481

BTP-44315

Details and patient eligibility

About

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

Full 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.

Enrollment: 74 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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74 participants in 4 patient groups

T-R cohort under fasted state

Experimental group

Description:

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.

Treatment:

Drug: ensartinib capsules (reference product)

Drug: ensartinib capsules (test product)

R-T cohort under fasted state

Experimental group

Description:

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.

Treatment:

Drug: ensartinib capsules (reference product)

Drug: ensartinib capsules (test product)

T-R cohort after meal

Experimental group

Description:

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.

Treatment:

Drug: ensartinib capsules (reference product)

Drug: ensartinib capsules (test product)

R-T cohort after meal

Experimental group

Description:

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.

Treatment:

Drug: ensartinib capsules (reference product)

Drug: ensartinib capsules (test product)