YH4808 Postprandial PK/PD Study in Healthy Subjects

Yuhan

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: YH4808

Study type: Interventional

Funder types: Industry

Identifiers

NCT01761513

YH4808-107

Details and patient eligibility

About

A clinical Study to evaluate the safety and pharmacokinetics/pharmacodynamics(PK/PD) of YH4808 after repeated Oral administration and Postprandial state in healthy volunteers

Enrollment: 21 patients

Sex: All

Ages: 20 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy male and female aged 20 to 55 with a body mass index(BMI) between 18.5 and 25 kg/m2
2. Subject who has no congenital, chronic diseases and disease symptoms in medical examination result
3. Subject who shows negative reaction of UBT(Urea Breath Test)
4. Subject who is judged to be eligible by principal investigator or sub-investigator according to various reasons including their abnormal test results (clinical laboratory test, chest X-ray test, 12-lead ECG etc) 4 weeks before the first IP adminitration
5. Medically acceptable contraception(including individuals who are medically unable to become pregnant) used during the clinical trial
6. Volunteers who has signed a written informed consent voluntarily, prior to any procedure, using a form that is approved by the local Institutional Review Board after detail explanation of the purpose, contents, and characteristic of the drug

Exclusion criteria

1. Subject who is hypersensitive to components contained in YH4808 or this drug
2. Subject who has history or presence of clinically significant diseases in liver, kidney, gastrointestinal tract, nervous system, respiratory system, endocrine system, blood tumor, cardiovascular, urinary system, and mental disorder
3. Subject who has history of surgical operation or diseases related to gastrointestinal symtem (e.g. crohn's disaese, ulcer etc except appendectomy or simple for herina)
4. Other exclusions apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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21 participants in 4 patient groups

Sequence 1

Experimental group

Treatment:

Drug: YH4808

Drug: YH4808

Drug: YH4808

Drug: YH4808

Sequence 2

Experimental group

Treatment:

Drug: YH4808

Drug: YH4808

Drug: YH4808

Drug: YH4808

Sequence 3

Active Comparator group

Treatment:

Drug: YH4808

Drug: YH4808

Drug: YH4808

Drug: YH4808

Sequence 4

Active Comparator group

Treatment:

Drug: YH4808

Drug: YH4808

Drug: YH4808

Drug: YH4808