Effect of Food Intake on Pharmacokinetic Profiles of Z-338

Astellas

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Z-338

Study type: Interventional

Funder types: Industry

Identifiers

NCT00920998

443-CL-503

Details and patient eligibility

About

To evaluate the effects of food intake on plasma concentration of Z-338 in healthy volunteers.

Full description

The purpose of the study is to evaluate the influence of food intake on the pharmacokinetic profiles of Z-338 in healthy volunteers by a 3-way cross-over method.

Enrollment: 30 patients

Sex: Male

Ages: 20 to 44 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy subject
• Body weight: 50.0 - 80.0 kg
• BMI: 17.6 - 26.4

Exclusion criteria

• Receiving an investigational new drug within 120 days of the study
• Receiving medical treatment drugs within 7 days of the study
• Blood donation before the study

Trial design

30 participants in 1 patient group

1. Z-338

Experimental group

Description:

3-way cross-over study (drug administration 3-times in fasted and 2 fed conditions)

Treatment:

Drug: Z-338