The Exploration for Pharmacodynamics and Pharmacokinetics of YH4808 New Formulation in Healthy Subjects

Yuhan

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: YH4808 NF 200; Drug: YH4808 NF 100; Drug: YH4808 OF 200; Drug: YH4808 NF 400

Study type: Interventional

Funder types: Industry

Identifiers

NCT02176668

YH4808-111

Details and patient eligibility

About

The objective of this clinical trial is to explore pharmacodynamics and pharmacokinetics of YH4808 New Formulation in healthy volunteers.

Enrollment: 82 patients

Sex: All

Ages: 19 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. healthy adult age 20 to 55 over 55kg with ideal body weight(BMI) 18.5 ~ 25
2. Subject who has no congenital, chronic disease and disease symptoms in medical examination result
3. negative to Helicobacter pylori in 13C urea breath test
4. Subject who judged to be eligible according to various test results including laboratory test(serum test, hematologic/blood chemistry examination, urine test, etc.) and 12-lead ECG test performed within 4 weeks before the first IP administration.
5. Subject who agreed to maintain contraception and comply with medically verified contraception methods (including infertility)

Exclusion criteria

1. Subject who has history or presence of clinically significant disease in liver, kidney, nervous system, respiratory system, endocrine system, blood tumor, cardiovascular, reproductive, musculoskeletal system, mental disorder, ophthalmologic disease, and skin disease in investigator's judgement.
2. Subject who has history of surgical operation or disease related to gastrointestinal symptoms (e.g. crohn's diseas, ulcer, etc. except for appendectomy or simple hernia) which could have influence on the absorption of IP.
3. Subject who is hypersensitive to components contained in YH4808 and other drugs(aspirin, antibiotics, etc.)
4. pregnant or lactating woman.
5. Other exclusions apply.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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82 participants in 10 patient groups

Cohort1-YH4808 NF 100

Experimental group

Description:

7 days repeat administration of YH4808 New Formulation 100mg after meal

Treatment:

Drug: YH4808 NF 100

Cohort1-YH4808 OF 200

Experimental group

Description:

(Partial cross over design) 7 days repeat administration of YH4808 Old Formulation 200mg after meal, 4 Weeks of wash out period, 7 days repeat administration of YH4808 New Formulation 200mg after meal

Treatment:

Drug: YH4808 OF 200

Drug: YH4808 NF 200

Cohort1-YH4808 NF 200

Experimental group

Description:

(Partial cross over design) 7 days repeat administration of YH4808 New Formulation 200mg after meal, 4 Weeks of wash out period, 7 days repeat administration of YH4808 Old Formulation 200mg after meal

Treatment:

Drug: YH4808 OF 200

Drug: YH4808 NF 200

Cohort1-YH4808 NF 400

Experimental group

Description:

7 days repeat administration of YH4808 New Formulation 400mg after meal

Treatment:

Drug: YH4808 NF 400

Cohort2-YH4808 NF 100

Experimental group

Description:

7 days repeat administration of YH4808 New Formulation 100mg before meal

Treatment:

Drug: YH4808 NF 100

Cohort2-YH4808 NF 200

Experimental group

Description:

(Partial cross over design) 7 days repeat administration of YH4808 New Formulation 200mg before meal, 4 Weeks of wash out period, 7 days repeat administration of YH4808 Old Formulation 200mg before meal

Treatment:

Drug: YH4808 OF 200

Drug: YH4808 NF 200

Cohort2-YH4808 OF 200

Experimental group

Description:

(Partial cross over design) 7 days repeat administration of YH4808 New Formulation 200mg before meal, 4 Weeks of wash out period, 7 days repeat administration of YH4808 Old Formulation 200mg before meal

Treatment:

Drug: YH4808 OF 200

Drug: YH4808 NF 200

Cohort2-YH4808 NF 400

Experimental group

Description:

7 days repeat administration of YH4808 New Formulation 400mg before meal

Treatment:

Drug: YH4808 NF 400

Cohort3-YH4808 OF 200

Experimental group

Description:

(Partial cross over design) 1. 7 days repeat administration of YH4808 Old Formulation 200mg before bed, 4 Weeks of wash out period, 7 days repeat administration of YH4808 Old Formulation 200mg before dinner 2. 7 days repeat administration of YH4808 Old Formulation 200mg before dinner, 4 Weeks of wash out period, 7 days repeat administration of YH4808 Old Formulation 200mg before bed

Treatment:

Drug: YH4808 OF 200

Cohort3-YH4808 OF 400

Experimental group

Description:

(Partial cross over design) 1. 7 days repeat administration of YH4808 Old Formulation 400mg before bed, 4 Weeks of wash out period, 7 days repeat administration of YH4808 Old Formulation 400mg before dinner 2. 7 days repeat administration of YH4808 Old Formulation 400mg before dinner, 4 Weeks of wash out period, 7 days repeat administration of YH4808 Old Formulation 400mg before bed

Treatment:

Drug: YH4808 OF 200