Phase 1 Clinical Trial to Investigate the Effect on the Pharmacokinetics of YH14755 Compared to Co-administration of Rosuvastatin and Metformin SR in Healthy Volunteers
NCT ID: NCT02125227
Last Updated: 2014-10-09
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
56 participants
INTERVENTIONAL
2014-04-30
2014-09-30
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
NONE
Study Groups
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Group 1 of Study A
single dosing of Rosuvastatin and Metformin 14 days later, single dosing of YH14755
Rosuvastatin, Metformin, YH14755
single dose
Group 2 of Study A
single dosing of YH14755 14 days later, single dosing of Rosuvastatin and Metformin
Rosuvastatin, Metformin, YH14755
single dose
Group 1 of Study B
single dosing of YH14755 with fasting state 14 days later, single dosing of YH14755 after having breakfast
YH14755
single dose
Group 2 of Study B
single dosing of YH14755 after having breakfast 14 days later, single dosing of YH14755 with fasting state
YH14755
single dose
Interventions
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Rosuvastatin, Metformin, YH14755
single dose
YH14755
single dose
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Who has not suffered from clinically significant disease
3. Provision of signed written informed consent
Exclusion Criteria
2. A history of drug abuse or the presence of positive reactions to drugs that have abuse potential in urine screenings for drugs.
3. Administration of other investigational products within 3 months prior to the first dosing.
4. Administration of herbal medicine within 4 weeks or administration of ethical drugs within 2 weeks or administration of over-the-counter (OTC) drugs within 1 week prior to the first dosing of the investigational product (if the investigator (study doctor) determines that the person meets other criteria appropriately, the relevant person may participate in the study).
5. Volunteers considered not eligible for the clinical trial by the investigator (study doctor) due to reasons including laboratory test results, ECGs, or vital signs.
19 Years
55 Years
ALL
Yes
Sponsors
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Yuhan Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Mingul Kim, MD, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Chonbuk National University Hospital
Locations
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Chonbuk National University Hospital
Jeonju, Jeollabuk-do, South Korea
Countries
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Other Identifiers
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YH14755-102
Identifier Type: -
Identifier Source: org_study_id
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