CompletedNCT01823133Updated Aug 28, 2013

Study for Investigate the Pharmacokinetic Drug Interactions Between Gemigliptin and Rosuvastatin

A Phase 1 interventional study of gemigliptin only and rosuvastatin only in Healthy, sponsored by LG Life Sciences. Completed at 1 site in South Korea. Open to male participants aged 20 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-08-28.

Sponsored by LG Life Sciences (part of LG Chem) · Phase 1, Interventional, and Treatment

Phase: Phase 1
Study type: Interventional
Enrollment: 30
Allocation: Randomized
Ages: 20 Years to 45 Years
Sex: Male

Study summary

Investigate the pharmacokinetic drug interactions between gemigliptin and rosuvastatin in healthy subjects

Conditions studied

Healthy

In context

Lead sponsor

LG Life Sciences is the lead sponsor of 78 studies on the registry; none are open to participants now.

First submitted before LG Life Sciences became part of LG Chem.

Browse LG Life Sciences studies →All LG Chem studies →

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 20 Years to 45 Years
Sexes eligible: Male
Accepts healthy volunteers: Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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)
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

Exclusion Criteria:

Subject who has past or present history of any diseases following below.(liver including hepatitis virus carrier, kidney, Neurology,immunology,pulmonary,endocrine,hematooncology,cardiology,mental disorder.)
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

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover assignment
Masking: None (open label)
Enrollment: 30 participants (estimated)

Study arms

Experimental
gemigliptin only
Multiple administrations of gemigliptin
Drug: gemigliptin only
Experimental
rosuvastatin only
Multiple administrations of rosuvastatin
Drug: rosuvastatin only
Experimental
gemigliptin and rosuvastatin
Multiple administrations of gemigliptin and rosuvastatin
Drug: gemigliptin and rosuvastatin

Interventions

Druggemigliptin only
gemigliptin 50mg qd on day 1\~7
Drugrosuvastatin only
rosuvastatin 20mg qd on day 1\~7
Druggemigliptin and rosuvastatin
gemigliptin 50mg, rosuvastatin 20mg qd on day 1\~7

What researchers measure

Primary outcomes

Cmax
to evaluate Cmax of gemigliptin and rosuvastatin at steady state
Time frame: up to 72 hour post dose
AUC
to evaluate AUCt of gemiglipin, rosuvastatin, and metabolite LC15-0636, N-desmethylrosuvastatin at steady state
Time frame: up to 72 hour post dose

Secondary outcomes

Tmax
to evaluate time of Cmax at steady state, gemiglipin, rosuvastatin, and metabolite LC15-0636, N-desmethylrosuvastatin
Time frame: up to 72 hour post dose
Cmin
to evaluate Cmin of gemigliptin and rosuvastatin at steady state
Time frame: upto 72 hour post dose
t1/2β
to evaluate half-life of gemiglipin, rosuvastatin, and metabolite LC15-0636, N-desmethylrosuvastatin
Time frame: upto 72 hour post dose
Cmax
to evaluate Cmax of metabolite LC15-0636, N-desmethylrosuvastatin at steady state
Time frame: upto 72 hour post dose
AUC
to evaluate AUC of metabolite LC15-0636, N-desmethylrosuvastatin at steady state
Time frame: upto 72 hour post dose
metabolic ratio
to evaluate metabolic ratio of gemiglipin and rosuvastatin
Time frame: upto 72 hour post dose

Study locations

1 site

Asan Medical Center
Seoul, South Korea

References and documents

Publications

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. PubMed 25350224 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Aug 28, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01823133
Lead sponsor: LG Life Sciences
Responsible party: Sponsor
First posted: Apr 4, 2013
Start date: Apr 2013
Primary completion: May 2013
Completion: Aug 2013
Last update: Aug 28, 2013

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2013. You cannot join it, but the record below documents what was studied.

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