Safety and Pharmacokinetic Characteristics After Administration of HIP1503 and HGP1103 in Healthy Male Volunteers
NCT ID: NCT02940314
Last Updated: 2016-10-20
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
36 participants
INTERVENTIONAL
2016-03-31
2016-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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sequence 1
HGP1103→HIP1503
HIP1503
HGP1103
Sequence 2
HIP1503→HGP1103
HIP1503
HGP1103
Interventions
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HIP1503
HGP1103
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. The result of Body Mass Index(BMI) 17.5 kg/m2\~ 30.5 kg/m2, body weight over 55kg.
3. Subjects who have ability to comprehend the objectives, contents of study and property of study drug before participating in trial and have willingness to sign of informed consent in writing.
Exclusion Criteria
2. Medical history of Gastrointestinal Diseases that effects drug absorption (esophageal disease, chronic disease) or surgery( except appendectomy , herniolaparotomy)
3. sit SBP \> 140 mmHg, sit DBP \> 90 mmHg
4. Alcohol or Drug abuse within 1 year
19 Years
45 Years
MALE
Yes
Sponsors
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Hanmi Pharmaceutical Company Limited
INDUSTRY
Responsible Party
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Other Identifiers
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HM-SOLT-101
Identifier Type: -
Identifier Source: org_study_id
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