Food Effect on Pharmacokinetics of YH4808 in Healthy Male Subjects

Yuhan

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: YH4808 100 mg; Drug: YH4808 300 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01520012

YH4808-102

Details and patient eligibility

About

The main objective is to evaluate the food effect on the pharmacokinetic profile of YH4808 100 mg b.i.d and YH4808 300 mg after oral administration in healthy male subjects.

Enrollment: 44 patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subjects who signed written consent after receiving thorough explanation on trial purpose, content, and characteristics of investigational drug
• Healthy male volunteers in the age between 20 to 45 years old
• Weight: over 50kg, within ±20% of ideal body weight
• Subjects who were determined to be appropriate through screening

Exclusion criteria

• Clinically significant disorder in liver, kidney, cardiovascular, respiratory system, endocrine system and CNS in the physical examination and clinical laboratory tests or a medical history of malignant tumor or psychological disease
• Medical history of gastrointestinal disease or acid restraining surgery, gastric/esophagus surgery (excluding appendectomy, hernia surgery)
• A history of hypersensitivity to drugs or clinically significant allergic disease
• Clinically significant abnormal values in blood chemistry(≥ 1.5 fold of normal upper limit in the levels of SGOT, SGPT)
• Subjects who had a history of drug abuse or who had a positive results on urine drug screening
• Subjects who had taken usual dose of any prescription drugs within 14 days before the treatment or who had used usual dose of OTC drugs within 7 days before the treatment(cf, be able to be enrolled in this study according to an investigatory consideration)
• Subjects who participated in another clinical trial within 2 months before enrolling in this study
• Subjects who donated whole blood within 2 months or component blood within 1 month or who are donated within 1 month before the treatment
• Subjects who drank Over 21 units/week of alcohol or subjects who were unable to stop drinking alcohol during the hospitalization
• Subjects who stopped smoking within 3 months before the treatment
• Subjects who had a beverage containing grapefruits within 24hrs before the hospitalization or who had a beverage containing grapefruits during the hospitalization
• Subjects who had a beverage containing caffeine during the hospitalization
• Subjects with clinically significant observations considered as unsuitable based on medical judgment by investigators

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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44 participants in 5 patient groups

Sequence 1

Experimental group

Treatment:

Drug: YH4808 100 mg

Drug: YH4808 100 mg

Sequence 2

Experimental group

Treatment:

Drug: YH4808 100 mg

Drug: YH4808 100 mg

Sequence 3

Experimental group

Treatment:

Drug: YH4808 300 mg

Drug: YH4808 300 mg

Drug: YH4808 300 mg

Sequence 4

Experimental group

Treatment:

Drug: YH4808 300 mg

Drug: YH4808 300 mg

Drug: YH4808 300 mg

Sequence 5

Experimental group

Treatment:

Drug: YH4808 300 mg

Drug: YH4808 300 mg

Drug: YH4808 300 mg