Food Effect on Pharmacokinetics of YH4808 in Healthy Male Subjects

NCT ID: NCT01520012

Last Updated: 2012-07-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2012-06-30

Brief Summary

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sequence 1

Group Type: EXPERIMENTAL

YH4808 100 mg

Intervention Type: DRUG

Period1: YH4808 100 mg bid fasting condition for 7days Period2: YH4808 100 mg bid fed condition for 7days

Sequence 2

Group Type: EXPERIMENTAL

YH4808 100 mg

Intervention Type: DRUG

Period1: YH4808 100 mg bid fed condition for 7days Period2: YH4808 100 mg bid fasting condition for 7days

Sequence 3

Group Type: EXPERIMENTAL

YH4808 300 mg

Intervention Type: DRUG

Period1: YH4808 300 mg fasting condition Period2: YH4808 300 mg fed condition(standard meal) Period3: YH4808 300 mg fed condition(high fat meal)

Sequence 4

Group Type: EXPERIMENTAL

YH4808 300 mg

Intervention Type: DRUG

Period1: YH4808 300 mg fed condition(high fat meal) Period2: YH4808 300 mg fasting condition Period3: YH4808 300 mg fed condition(standard meal)

Sequence 5

Group Type: EXPERIMENTAL

YH4808 300 mg

Intervention Type: DRUG

Period1: YH4808 300 mg fed condition(standard meal) Period2: YH4808 300 mg fed condition(high fat meal) Period3: YH4808 300 mg fasting condition

Interventions

YH4808 100 mg

Period1: YH4808 100 mg bid fasting condition for 7days Period2: YH4808 100 mg bid fed condition for 7days

Intervention Type: DRUG

YH4808 100 mg

Period1: YH4808 100 mg bid fed condition for 7days Period2: YH4808 100 mg bid fasting condition for 7days

Intervention Type: DRUG

YH4808 300 mg

Period1: YH4808 300 mg fasting condition Period2: YH4808 300 mg fed condition(standard meal) Period3: YH4808 300 mg fed condition(high fat meal)

Intervention Type: DRUG

YH4808 300 mg

Period1: YH4808 300 mg fed condition(high fat meal) Period2: YH4808 300 mg fasting condition Period3: YH4808 300 mg fed condition(standard meal)

Intervention Type: DRUG

YH4808 300 mg

Period1: YH4808 300 mg fed condition(standard meal) Period2: YH4808 300 mg fed condition(high fat meal) Period3: YH4808 300 mg fasting condition

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Yuhan Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kyung-Sang Yu, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

Yuhan Corporation

Seoul, , South Korea

Countries

South Korea

References

Kim E, Kim A, Yi S, Kim YK, Jang SB, Byun HM, Yoon SH, Cho JY, Jang IJ, Yu KS, Lee S. Effect of food on the pharmacokinetics of YH4808, a potassium-competitive acid blocker, after single- and multiple-oral dosing in healthy subjects. Eur J Clin Pharmacol. 2018 Oct;74(10):1261-1272. doi: 10.1007/s00228-018-2502-9. Epub 2018 Jun 15.

Reference Type: DERIVED

PMID: 29907887 (View on PubMed)

Other Identifiers

YH4808-102

Identifier Type: -

Identifier Source: org_study_id