BE Study of the Combinations of Gemigliptin 50mg and Metformin HCl Extended Release 2000mg in Comparison to Each Component Administered Alone

Healthy Clinical Trial

Official title:

A Randomized, Open-label, Single-dose, Two-way Crossover Clinical Trial to Investigate the Pharmacokinetics and Safety/Tolerability of the Combination of Gemigliptin/Metformin HCl Sustained Release 50/2000 mg(25/1000 mg x 2 Tablets) in Comparison to Each Component Gemigliptin 50 mg and Metformin HCl Extended Release 2000 mg(1000 mg x 2 Tablets) Administered in Healthy Male Volunteers

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02670018
• Other study ID #: LG-DMCL005
• Status: Enrolling by invitation
• Phase: Phase 1
• First received: December 22, 2015
• Last updated: January 31, 2016
• Start date: August 2015
• Est. completion date: March 2016

Study information

• Verified date: January 2016
• Source: LG Life Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial Summary

A Randomized, Open-label, Single-dose, Two-way Crossover Clinical Trial to Investigate the Pharmacokinetics and Safety/Tolerability of the Combination of Gemigliptin/Metformin HCl Sustained Release 50/2000 mg(25/1000 mg x 2 tablets) in Comparison to Each Component Gemigliptin 50 mg and Metformin HCl Extended Release 2000 mg (1000 mg x 2 tablets) Administered in Healthy Male Volunteers.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 25
• Est. completion date: March 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 45 Years

Eligibility

Inclusion Criteria:

• Age between 19 to 45, healthy male subjects(at screening)

• Body weight between 55kg - 90kg, BMI between 18.0 - 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 3months

• Subject who had whole blood donation in 2months, or component blood donation in 1months or transfusion in 1months 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, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• gemigliptin and metformin HCl extended release
Coadministration of gemigliptin 50mg and metformin HCl extended release 1000mg * 2 tablets, for 1 day
• gemigliptin/metformin HCl extended release
Administration of combination of gemigliptin 25mg/metformin HCl extended release 1000mg * 2 tablets, for 1day

Locations

Country	Name	City	State
Korea, Republic of	Yonsei University College of Medicine	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 48h post-dose	No
Primary	Cmax	To evaluate Cmax of gemigliptin and metformin	up to 48h post-dose	No
Secondary	Tmax of Gemigliptin, Metformin		up to 48h post-dose	No
Secondary	AUCinf of Gemigliptin, Metformin		up to 48h post-dose	No
Secondary	t1/2 of Gemigliptin, Metformin		up to 48h post-dose	No
Secondary	CL/F of Gemigliptin, Metformin		up to 48h post-dose	No
Secondary	Vd/F of Gemigliptin, Metformin		up to 48h post-dose	No
Secondary	AUC0-48h of Gemigliptin metabolite(LC15-0636)		up to 48h post-dose	No
Secondary	Cmax of Gemigliptin metabolite(LC15-0636)		up to 48h post-dose	No
Secondary	Tmax of Gemigliptin metabolite(LC15-0636)		up to 48h post-dose	No
Secondary	AUCinf of Gemigliptin metabolite(LC15-0636)		up to 48h post-dose	No
Secondary	t1/2 of Gemigliptin metabolite(LC15-0636)		up to 48h post-dose	No
Secondary	CL/F of Gemigliptin metabolite(LC15-0636)		up to 48h post-dose	No
Secondary	Vd/F of Gemigliptin metabolite(LC15-0636)		up to 48h post-dose	No
Secondary	metabolic ratio(MR) of Gemigliptin metabolite(LC15-0636)		up to 48h post-dose	No