Study for Investigate the Pharmacokinetic Drug Interactions Between Gemigliptin and Rosuvastatin

NCT01823133 | Completed Phase 1 DMC

• 1 other identifier: LG-GSCL001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Cmax

  to evaluate Cmax of gemigliptin and rosuvastatin at steady state

  up to 72 hour post dose

• AUC

  to evaluate AUCt of gemiglipin, rosuvastatin, and metabolite LC15-0636, N-desmethylrosuvastatin at steady state

  up to 72 hour post dose

Secondary Outcomes (6)

• Tmax

  up to 72 hour post dose

• Cmin

  upto 72 hour post dose

• t1/2β

  upto 72 hour post dose

• Cmax

  upto 72 hour post dose

• AUC

  upto 72 hour post dose

Study Arms (3)

gemigliptin only

EXPERIMENTAL

Multiple administrations of gemigliptin

Drug: gemigliptin only

rosuvastatin only

EXPERIMENTAL

Multiple administrations of rosuvastatin

Drug: rosuvastatin only

gemigliptin and rosuvastatin

EXPERIMENTAL

Multiple administrations of gemigliptin and rosuvastatin

Drug: gemigliptin and rosuvastatin

Interventions

gemigliptin only DRUG

gemigliptin 50mg qd on day 1\~7

gemigliptin only

rosuvastatin only DRUG

rosuvastatin 20mg qd on day 1\~7

rosuvastatin only

gemigliptin and rosuvastatin DRUG

gemigliptin 50mg, rosuvastatin 20mg qd on day 1\~7

gemigliptin and rosuvastatin

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• LG Life Sciences: lead

Study Sites (1)

Asan Medical Center

Seoul, South Korea

Location

Related Publications (1)

• 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.

  PMID: 25350224 DERIVED

MeSH Terms

Interventions

LC15-0444; Rosuvastatin Calcium

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2013
• First Posted: April 4, 2013
• Study Start: April 1, 2013
• Primary Completion: May 1, 2013
• Study Completion: August 1, 2013
• Last Updated: August 28, 2013

Record last verified: 2013-08

Locations

KR (1)