Overview

To Evaluate the Safety, Tolerability, PK, PK-PD Relation of KD101 in the Fed State in Obese or Overweight Subjects

Status:
Unknown status
Trial end date:
2016-03-01
Target enrollment:
0
Participant gender:
All
Summary
To Evaluate the safety, tolerability and pharmacokinetic property after KD101 multiple oral dosing in the fed state in obese or overweight subjects.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Kwang Dong Pharmaceutical co., ltd.
Criteria
Inclusion Criteria:

- Male or Female adults aged 20 to 55 at screening (Part II : Male adults aged 20 to 55
at screening)

- Healthy volunteer whose BMI ≥ 27 (Part II : Healthy volunteer whose BMI ≥ 18)

- Female who are not pregnancy possibility or Male/Female who can abstinence or
contraception during clinical trials

Exclusion Criteria:

- Subjects who had clinically significant disease history
(liver,kidney,nervous,pulmonary,endocrinal,urinary,cardiovascular,musculoskeletal,ment
al system,blood,tumor) or diagnosed within 1 month from screening

- Subjects who had gastrointestinal disease(Crohn's disease, ulcer, acute/chronic
pancreatitis) that affect the absorption of test drug or gastrointestinal operation
(However, appendectomy, herniotomy induced by acute appendicitis are excluded)

- Subjects who had following history. [myocardial infarction (diagnosed by cardiac
enzyme and/or diagnostic ECG), cerebral infarction/stroke, arrhythmia needed to
medical treatment, unstable angina, pulmonary hypertension]

- Subjects who had positive result to Human Immunodeficiency Virus, Hepatitis B virus,
Hepatitis C virus during screening

- Subjects who had allergy history (ex. allergy for aspirin, antibiotics, etc) or had
clinically-significant allergy

- Subjects whose systolic BP was <85mmHg or >145mmHg, or diastolic BP was <50mmHg or
>95mmHg, or pulse was >100/min after 3 minute-seating position. (BP can be re-measured
twice at leat 5 minute-interval)

- Subjects who would take prescribed/oriental drug(within 2 weeks from the first dosing
day) or OTC drug or vitamines (within 1 weeks from the first dosing day)

- Subjects who drink over than 21 unit (1 unit = 10g of pure alcohol) or cannot quit
drinking alcohol during clinical trial period

- Subjects who ate following food within 2 days from the first dosing day or cannot quit
following food [grapefruit-contain food, caffein-contain food(coffee, green tea, black
tea, soft drink, coffee milk, energy drink)]

- Subjects who didn't agree contraception

- Subjects who didn't agree to quit smoke

- Subjects who donated his/her blood within 2 months (whole blood) / 1 month (apheresis)
or who took transfusion within 1 month

- Subjects who participated another clinical trials within 3 months from first dosing
day. (The clinical trial completion day is defined as the last dosing day of past
clinical trial)

- Subjects who are not adequate to this trial by lab examination and another reasons

- Subjects who weighed loss more than 5kg in 3 months