Pharmacokinetic Drug Interaction Study Between Gemigliptin and Irbesartan After Oral Administration in Healthy Male Subjects

NCT01825850 | Completed Phase 1

• 1 other identifier: LG-GBCL001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of the study is to investigate the drug interaction between Gemigliptin and Irbesartan by comparing pharmacokinetics of Gemigliptin and Irbesartan administered concomitantly and each alone in healthy male subjects.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Cmax,ss

  To evaluate Cmax,ss of Gemigliptin and Irbesartan

  up to 72h post-dose

• AUCτ,ss

  To evaluate AUCτ,ss of Gemigliptin and Irbesartan

  up to 72h post-dose

Secondary Outcomes (5)

• Cmin,ss

  up to 72h post-dose

• Tmax,ss

  up to 72h post-dose

• Cmax,ss

  up to 72h post-dose

• AUCτ,ss

  up to 72h post-dose

• metabolic ratio

  up to 72h post-dose

Study Arms (3)

Gemigliptin

EXPERIMENTAL

Gemigliptin 50mg q.d. during 7 days

Drug: Gemigliptin

Irbesartan

EXPERIMENTAL

Irbesartan 300mg q.d. during 7 days

Drug: Irbesartan

Gemiglitin + Irbesartan

EXPERIMENTAL

Gemigliptin 50mg + Irbesartan 300mg q.d. during 7 days

Drug: Gemigliptin; Drug: Irbesartan

Interventions

Gemigliptin DRUG

Gemigliptin; Gemiglitin + Irbesartan

Irbesartan DRUG

Gemiglitin + Irbesartan; Irbesartan

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, irbesartan, 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; Irbesartan

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Spiro Compounds; Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds

Study Design

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

Study Record Dates

• First Submitted: April 3, 2013
• First Posted: April 8, 2013
• Study Start: June 1, 2013
• Primary Completion: September 1, 2013
• Study Completion: March 1, 2014
• Last Updated: December 30, 2014

Record last verified: 2014-12

Locations

KR (1)