Study for Investigate the Pharmacokinetic Drug Interactions Between Gemigliptin and Rosuvastatin

LG Life Sciences

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: gemigliptin only; Drug: gemigliptin and rosuvastatin; Drug: rosuvastatin only

Study type: Interventional

Funder types: Industry

Identifiers

NCT01823133

LG-GSCL001

Details and patient eligibility

About

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

Enrollment: 30 estimated patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

gemigliptin only

Experimental group

Description:

Multiple administrations of gemigliptin

Treatment:

Drug: gemigliptin only

rosuvastatin only

Experimental group

Description:

Multiple administrations of rosuvastatin

Treatment:

Drug: rosuvastatin only

gemigliptin and rosuvastatin

Experimental group

Description:

Multiple administrations of gemigliptin and rosuvastatin

Treatment:

Drug: gemigliptin and rosuvastatin