NCT03510611

A Study to Investigate the Food Effect on the Pharmacokinetics of Ensartinib Capsules in Chinese Healthy Volunteers.

A Pharmacokinetic Study in Chinese Healthy Male and Female Volunteers to Investigate the Effect of Food on the Pharmacokinetics of Ensartinib Capsules.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Betta Pharmaceuticals Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The main objective of this study is to evaluate the Effect of Food on the Pharmacokinetics of Ensartinib Capsules.

Detailed description

The main objective of this study is to evaluate the Effect of Food on the Pharmacokinetics of Ensartinib Capsules in Chinese Healthy Volunteers. In addition, the safety of Ensartinib Capsules in Chinese Healthy Volunteers who with High-fat meal or fasting state will also be evaluated.

Conditions

• Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Ensartinib with fed or fasting	The two groups of subjects were given an equal dose of Ensartinib capsules (225 mg) after a single cross-over fasting or high-fat high-calorie diet in two different test cycles to examine the effect of food on the pharmacokinetics of Ensartinib.

Timeline

• Start date: 2018-03-12
• Primary completion: 2018-08-02
• Completion: 2018-08-02
• First posted: 2018-04-27
• Last updated: 2019-07-24

Locations

1 site across 1 country: China