Effect of a High-fat Meal on the Pharmacokinetics of SHR0302 and Mass Balance Study in Healthy Subjects

Hengrui Medicine

Status and phase: Unknown; Phase 1

Conditions: Rheumatoid Arthritis

Treatments: Drug: SHR0302

Study type: Interventional

Funder types: Industry

Identifiers

NCT02892370

SHR0302-103

Details and patient eligibility

About

The purpose of this open-label, randomized, two-period, two-treatment (single doses of 10 mg SHR0302 fasted or fed), crossover study was to evaluate the effect of a high-fat meal on the pharmacokinetics of SHR0302 and mass balance study in 14 healthy subjects.

Enrollment: 14 estimated patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male
• BMI:19-24 kg/m2, weight > 50 kg.
• Age:18-45

Exclusion criteria

• History of clinically significant laboratory results or disease.
• History of alcohol or drug abuse.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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14 participants in 2 patient groups

SHR0302 fasted to fed

Experimental group

Description:

SHR0302 tablets (10 mg) administered on day 1 fasting, and day 7 with high fat, high calorie breakfast

Treatment:

Drug: SHR0302

SHR0302 fed to fasted

Experimental group

Description:

SHR0302 tablets (10 mg) administered on day 1 with high fat, high calorie breakfast, and day 7 fasting

Treatment:

Drug: SHR0302