Completed
A Randomized, Open Label Crossover Study to Investigate the Pharmacokinetic Drug Interactions Between Gemigliptin and Rosuvastatin in Healthy Male Subjects
What is being tested
gemigliptin only
+ rosuvastatin only
+ gemigliptin and rosuvastatin
Drug
Who is being recruted
From 20 to 45 Years
+10 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 1
Interventional
Study Start: April 2013
Summary
Principal SponsorLG Life Sciences
Last updated: August 28, 2013
Sourced from a government-validated database.Claim as a partner
Study start date: April 1, 2013
Actual date on which the first participant was enrolled.Investigate the pharmacokinetic drug interactions between gemigliptin and rosuvastatin in healthy subjects
Principal SponsorLG Life Sciences
Last updated: August 28, 2013
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
30 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Criteria
Male
Biological sex of participants that are eligible to enroll.From 20 to 45 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
5 inclusion criteria required to participate
Age between 20 to 45, healthy male subjects (at screening)
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)
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5 exclusion criteria prevent from participating
Subject who already admitted in other investigator product in 80 days
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 had whole blood donation in 60 days, or component blood donation in 30 days or transfusion in 30 days currently
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Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
3 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalMultiple administrations of gemigliptin
Group II
ExperimentalMultiple administrations of rosuvastatin
Group III
ExperimentalMultiple administrations of gemigliptin and rosuvastatin
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
CompletedOne Study Center