Study for Investigate the Pharmacokinetic Drug Interactions Between Gemigliptin and Rosuvastatin
NCT ID: NCT01823133
Last Updated: 2013-08-28
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
30 participants
INTERVENTIONAL
2013-04-30
2013-08-31
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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gemigliptin only
Multiple administrations of gemigliptin
gemigliptin only
gemigliptin 50mg qd on day 1\~7
rosuvastatin only
Multiple administrations of rosuvastatin
rosuvastatin only
rosuvastatin 20mg qd on day 1\~7
gemigliptin and rosuvastatin
Multiple administrations of gemigliptin and rosuvastatin
gemigliptin and rosuvastatin
gemigliptin 50mg, rosuvastatin 20mg qd on day 1\~7
Interventions
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gemigliptin only
gemigliptin 50mg qd on day 1\~7
rosuvastatin only
rosuvastatin 20mg qd on day 1\~7
gemigliptin and rosuvastatin
gemigliptin 50mg, rosuvastatin 20mg qd on day 1\~7
Eligibility Criteria
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Inclusion Criteria
* BMI between 18 - 27 kg/m2 (at screening)
* Blood pressure SBP 90-140 mmHg, DBP 60-95 mmHg
* FPG 70-125mg/dL glucose level (at screening)
* Subject who totally understand the progress of this clinical trials, make decision by his free will, and signed a consent form to follow the
Exclusion Criteria
* Subject who had GI tract disease that influencable to drug absorption or(ulcer, acute or chronic pancreatitis) surgery.(appendectomy, hernioplasty are not included)
* Subject who had drug hypersensitivity reaction.(gemigliptin, rosuvastatin, aspirin, antibiotics)
* Subject who already admitted in other investigator product in 80 days
* Subject who had whole blood donation in 60 days, or component blood donation in 30 days or transfusion in 30 days currently
20 Years
45 Years
MALE
Yes
Sponsors
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LG Life Sciences
INDUSTRY
Responsible Party
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Locations
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Asan Medical Center
Seoul, , South Korea
Countries
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References
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Choi HY, Lim HS, Kim YH, Jeon HS, Kim MJ, Lee SH, Jung JH, Lee YK, Kim HJ, Bae KS. Evaluation of the pharmacokinetics of the DPP-4 inhibitor gemigliptin when coadministered with rosuvastatin or irbesartan to healthy subjects. Curr Med Res Opin. 2015 Feb;31(2):229-41. doi: 10.1185/03007995.2014.980886. Epub 2014 Nov 6.
Other Identifiers
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LG-GSCL001
Identifier Type: -
Identifier Source: org_study_id