Study for Investigate the Pharmacokinetic Drug Interactions Between Gemigliptin and Rosuvastatin

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: gemigliptin and rosuvastatin; Drug: gemigliptin only; Drug: rosuvastatin only

• Registration Number: NCT01823133
• Lead Sponsor: LG Life Sciences

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-03-28
• Study First Submitted QC: 2013-03-28
• Study Start: 2013-04
• Study First Posted: 2013-04-04
• Primary Completion: 2013-05
• Status Verified: 2013-08
• Study Completion: 2013-08
• Last Update Submitted: 2013-08-27
• Last Update Posted: 2013-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 30

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

• 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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
gemigliptin and rosuvastatin	gemigliptin and rosuvastatin	Multiple administrations of gemigliptin and rosuvastatin
gemigliptin only	gemigliptin only	Multiple administrations of gemigliptin
rosuvastatin only	rosuvastatin only	Multiple administrations of rosuvastatin

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of