BE Study of the Combinations of Gemigliptin 50mg and Rosuvastatin 20mg 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, Safety, and Tolerability of the Combination of Gemigliptin/Rosuvastatin 50/20 mg in Comparison to Each Component Gemigliptin 50 mg and Rosuvastatin 20 mg Administered in Healthy Male Volunteers

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02670070
• Other study ID #: LG-GSCL003
• Status: Enrolling by invitation
• Phase: Phase 1
• First received: December 22, 2015
• Last updated: May 10, 2016
• Start date: March 2016
• Est. completion date: June 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

This study is to evaluate the safety/tolerability and pharmacokinetics of the combinations of gemigliptin 50mg and rosuvastatin 20mg in comparison to each component administered alone in healthy male volunteers.

Description:

This study is to evaluate the safety/tolerability and pharmacokinetics(AUC and Cmax) of the combinations of gemigliptin 50mg and rosuvastatin 20mg in comparison to each component administered alone in healthy male volunteers.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 37
• Est. completion date: June 2016
• Est. primary completion date: April 2016
• 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)

• 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 2months

• Subject who had whole blood donation in 2 months, or component blood donation in 1 month or transfusion in 1 month currently.

• Heavy smokers.(>10 cigarettes per day)

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• gemigliptin 50mg, rosuvastatin 20mg
gemigliptin/rosuvastatin 50/20mg

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	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, Cmax	To evaluate AUClast/Cmax of gemigliptin and rosuvastatin	up to 72h post-dose	No
Secondary	AUCinf	To evaluate AUCinf of gemigliptin, LC15-0636 of gemigliptin metabolite and rosuvastatin	up to 72h post-dose	No
Secondary	Tmax	To evaluate Tmax of gemigliptin, LC15-0636 of gemigliptin metabolite and rosuvastatin	up to 72h post-dose	No
Secondary	t1/2	To evaluate t1/2 of gemigliptin, LC15-0636 of gemigliptin metabolite and rosuvastatin	up to 72h post-dose	No
Secondary	CL/F	To evaluate CL/F of gemigliptin, LC15-0636 of gemigliptin metabolite and rosuvastatin	up to 72h post-dose	No
Secondary	metabolic ratio	To evaluate metabolic ratio of gemigliptin, LC15-0636 of gemigliptin metabolite	up to 72h post-dose	No
Secondary	AUEC	This parameter is been used to measure pharmarcodynamic characters of gemigliptin, the supression rate of DPP4 activity.	up to 72h post-dose	No
Secondary	Emax	This parameter is been used to measure pharmarcodynamic characters of gemigliptin, the supression rate of DPP4 activity.	up to 72h post-dose	No