Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
41 participants
INTERVENTIONAL
2010-02-28
2010-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
TRIPLE
Study Groups
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Cohort1
HM11260C 0.5mcg/kg or Placebo
HM11260C
HM11260C 0.5mcg/kg or Placebo
Cohort2
HM11260C 2mcg/kg or Placebo
HM11260C
HM11260C 2mcg/kg or Placebo
Cohort3
HM11260C 4mcg/kg or Placebo
HM11260C
HM11260C 4mcg/kg or Placebo
Cohort4
HM11260C 8mcg/kg or Placebo
HM11260C
HM11260C 8mcg/kg or Placebo
Cohort5
HM11260C 14mcg/kg or Placebo
HM11260C
HM11260C 14mcg/kg or Placebo
Interventions
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HM11260C
HM11260C 0.5mcg/kg or Placebo
HM11260C
HM11260C 2mcg/kg or Placebo
HM11260C
HM11260C 4mcg/kg or Placebo
HM11260C
HM11260C 8mcg/kg or Placebo
HM11260C
HM11260C 14mcg/kg or Placebo
Eligibility Criteria
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Inclusion Criteria
2. Weight\>50 and \< 90kg, Body mass index of \>18 and \<27 Subject is informed of the investigational nature of this study and voluntarily agrees to participate in this study
Exclusion Criteria
2. Has previously disease which affect drug absorption, distribution, metabolism, excretion (e.g., inflammatory gastric disease, gastric or intestinal ulcer, hepatic disease, renal disease)
3. History or presence of clinically significant and active cardiovascular, pulmonary, renal, endocrine, hematological, gastrointestinal, central nervous system, psychiatric disorder, autoimmune disease, or malignant tumor
4. Has unsuitable clinical test results through the medical checkup, within 35 days prior to start of administration of study drug (medical history, physical examination, ECG, laboratory test)
5. Laboratory test results
1. AST (sGOT) or ALT (sGPT) \> 1.25Xupper normal limit
2. Total bilirubin \> 1.5Xupper normal limit
3. Absolute Neutrophil Count \< 1500 mm2
6. History or presence of clinically significant allergic disease (including mild allergic rhinitis and allergic dermatitis which is not necessary to medication)
7. Prior exposure to products related to Exenatide
8. Use of any prescription medication within 14 days prior to Day 1
9. Use of any medication within 7 days prior to Day 1 (over-the-counter medication, herbal products, nutrient, vitamins)
10. Subject who can't eat standard meal received by Korea University Anam Hospital
11. Donor of whole blood for transfusion within 60 days prior to start of study drug administration or donor of apheresis within 20 days or Receiver of blood transfusion within 1 month
12. Participation in another clinical study within 60 days prior to start of study drug administration
13. Taking Caffein(\> 5cups/ day) or alcohol abuse (\> 30g/ day) or excessive smoker(\> 10 Subject is informed of the investigational nature of this study and voluntarily agrees to participate in this study
20 Years
45 Years
MALE
Yes
Sponsors
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Hanmi Pharmaceutical Company Limited
INDUSTRY
Responsible Party
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Principal Investigators
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Hanmi Clinical
Role: PRINCIPAL_INVESTIGATOR
Korea
Other Identifiers
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HM-EXC-101
Identifier Type: -
Identifier Source: org_study_id
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