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

Hengrui Medicine

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Hetrombopag Olamine

Study type: Interventional

Funder types: Industry

Identifiers

NCT02409394

TPOP1c

Details and patient eligibility

About

This open-label, randomized, two-period, two-treatment (single doses of 7.5 mg hetrombopag fasted or fed), crossover study was conducted to evaluate the effect of a high-fat meal on the pharmacokinetics of hetrombopag 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.
• Weight≥50 kg，19≤BMI≤28 kg/m2.
• Platelet count is within normal range

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

hetrombopag 7.5mg fasted to fed

Experimental group

Description:

Hetrombopag tablet, fasting conditions on day 1; 9 days wash-out; Than subjects will be crossover to have hetrombopag tablet with high fat, high calorie breakfast on day 11.

Treatment:

Drug: Hetrombopag Olamine

hetrombopag 7.5mg fed to fasted

Experimental group

Description:

Hetrombopag tablet with high fat, high calorie breakfast on day 1; 9 days wash-out; Than subjects will be crossover to have hetrombopag tablet, under fasting condition on day 11.

Treatment:

Drug: Hetrombopag Olamine