Effect of a High-fat Meal on the Pharmacokinetics of SHR3824 and Mass Balance Study in Healthy Subjects

Hengrui Medicine

Status and phase: Completed; Phase 1

Conditions: Type 2 Diabetes

Treatments: Drug: SHR3824

Study type: Interventional

Funder types: Industry

Identifiers

NCT02353975

SHR3824-104

Details and patient eligibility

About

This open-label, randomized, two-period, two-treatment (single doses of 10 mg SHR3824 fasted or fed), crossover study was conducted to evaluate the effect of a high-fat meal on the pharmacokinetics of SHR3824 and mass balance study in 12 healthy subjects.

Enrollment: 12 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy.
• BMI 18-25 kg/m2.

Exclusion criteria

• History of clinically significant illness.
• 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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12 participants in 2 patient groups

SHR3824 10mg fasted to fed

Experimental group

Description:

SHR3824 tablet, fasting conditions day 1, visit 2, 7 days wash-out, SHR3824 tablet, high fat, high calorie breakfast day 1, visit 3.

Treatment:

Drug: SHR3824

SHR3824 10mg fed to fasted

Experimental group

Description:

SHR3824, high fat, high calorie breakfast day 1, visit 2, 7 days wash-out, SHR3824, fasting conditions day 1, visit 3.

Treatment:

Drug: SHR3824