Food-Effect Bioavailability Study of FDC(Gemigliptin/Metformin HCl Sustained Release) 50/1000mg(25/500mg x 2tablets)

Type 2 Diabetes Clinical Trial

Official title:

A Randomized, Open Label, Single Dose, Crossover Study to Investigate Food-effect Bioavailability of FDC(Gemigliptin/Metformin HCl Sustained Release) 50/1000mg(25/500mg x 2tablets)Under Fed and Fasting Conditions in Healthy Male Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01747083
• Other study ID #: LG-DMCL003
• Status: Completed
• Phase: Phase 1
• First received: November 30, 2012
• Last updated: October 22, 2013
• Start date: January 2013
• Est. completion date: April 2013

Study information

• Verified date: October 2013
• Source: LG Life Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: South korea: Korea Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study is designed to investigate the food-effects on FDC(gemigliptin/metformin HCl sustained release) 50/1000mg(25/500mg x 2tablets)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: April 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 45 Years

Eligibility

Inclusion Criteria:

• Age between 20 to 45, healthy male subjects(at screening)

• BMI between 19.0 - 27.0

• 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 progress.

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 or(ulcer, acute or chronic pancreatitis) surgery.(appendectomy, hernioplasty are not included)

• Subject who had drug hypersensitivity reaction.(Aspirin, antibiotics)

• Subject who already participated in other trials in 90 days

• Subject who had whole blood donation in 60 days, or component blood donation in 30 days or transfusion in 30 days currently.

• Smokers.(but, if the subject did'nt smoke in 3months, can participate the trial)

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Type 2 Diabetes

Intervention

Drug:
• FDC(gemigliptin/metformin HCl sustained release 50/1000mg(25/500mg x 2tablets))

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
LG Life Sciences

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUClast	To evaluate AUClast of gemigliptin and metformin	up to 48 h post-dose	No
Primary	Cmax	TO evaluate Cmax of gemigliptin and metformin	up to 48 h post-dose	No
Secondary	AUCinf	To evaluate AUCinf of gemigliptin,metformin and LC15-0636(active metabolite of gemigliptin)	up to 48 h post-dose	No
Secondary	Tmax	To evaluate Tmax of gemigliptin, metformin and LC15-0636(active metabolite of gemigliptim)	up to 48h post-dose	No
Secondary	t1/2	To evaluate t1/2 of gemigliptin, metformin and LC15-0636(active metabolite of gemigliptim)	up to 48 h post-dose	No
Secondary	Cmax	To evaluate Cmax of LC15-0636(active metabolite of gemigliptim)	up to 48h post-dose	No
Secondary	AUClast	To evaluate AUClast of LC15-0636(active metabolite of gemigliptim)	up to 48h post-dose	No