A phase 1/2a trial to evaluate the pharmacokinetics and pharmacodynamics of YH12852 IR, DR1 and DR2.
- Conditions
- Diseases of the digestive system
- Registration Number
- KCT0001956
- Lead Sponsor
- Seoul National University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 120
1.Subjects must be willing and able to provide written informed consent.
2.BMI within the range 18 to 25 kg/m2.
3.Males and females between 19 and 60 years of age.
1.History of positive serologic evidence for infectious disease including HBsAg, anti-HCV, anti-HIV.
2.Clinically significant lab/ECG abnormalities in the opinion of the investigator.
3.WOCBP(Women of Childbearing Potential) who are unwilling or unable to use an adequate contraceptive method to avoid pregnancy for the entire study. WOCBP(Women of Childbearing Potential) include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, bilateral tubectomy, or bilateral oophorectomy) or is not postmenopausal. Post menopause is defined as amenorrhea for = 12 consecutive months without another cause.
Clinically acceptable contraceptive methods for this study: intrauterine devices (e.g., loop), physical barrier method (e.g., diaphragm, uterine cap, condom) with chemical barrier method (e.g., spermicide), sterile partner, practicing abstinence.
4.WOCBP(Women of Childbearing Potential) who are willing to use hormonal methods or hormone-releasing device(e.g., mirena, implanon) for the entire study.
5.WOCBP(Women of Childbearing Potential) who are pregnant or breastfeeding.
6.WOCBP(Women of Childbearing Potential) with a positive pregnancy test prior to randomization.
7.Males who have not received a vasectomy must agree to use contraceptive methods defined in (a) and refrain from donating sperm throughout the study.
8.Presence of uncontrolled or severe medical illness.
9.Presence of a disease that require surgery at any time during the study.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cmax, AUC0-24 ? Tmax of Day1 ;trough concentrations on Day5, 10, 12, 13, 14 pre-dose
- Secondary Outcome Measures
Name Time Method Stool assessment;PATIENT ASSESSMENT OF CONSTIPATION-SYMPTOM/PATIENT ASSESSMENT OF GASTROINTESTINAL-SYMPTOM/PATIENT ASSESSMENT OF CONSTIPATION -QUALITY OF LIFE Questionaire