BE Study of the Combinations of Gemigliptin 50mg and Rosuvastatin 20mg in Comparison to Each Component Administered Alone

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2016-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study for Investigate the Pharmacokinetic Drug Interactions Between Gemigliptin and Rosuvastatin

NCT01823133

Healthy

COMPLETED PHASE1

A Study to Compare the Pharmacokinetics of DP-R207 in Comparison to Each Component Administered Alone

NCT02730689

Healthy Volunteers

COMPLETED PHASE1

Investigating the Pharmacokinetic Drug Interactions Between Rosuvastatin and Ezetimibe

NCT02127320

Healthy

COMPLETED PHASE1

Clinical Comparison of Low-dose Rosuvastatin Plus Ezetimibe Combination Therapy and High-dose Rosuvastatin Monotherapy in Patients With Minimal to Intermediate Coronary Artery Disease Without Percutaneous Coronary Intervention

NCT06186037

Coronary Artery Disease Dyslipidemias Primary Prevention

RECRUITING PHASE4

A Study to Compare the Pharmacokinetics and Safety of a Fixed Dose Combination of Fimasartan/Amlodipine/Rosuvastatin

NCT02995720

Hypertension, Hyperlipidemia

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Coadministration of G+R

Coadministration of gemigliptin 50mg and rosuvastatin 20mg

Group Type ACTIVE_COMPARATOR

gemigliptin 50mg, rosuvastatin 20mg

Intervention Type DRUG

gemigliptin/rosuvastatin 50/20mg

Combination G/R

Combination of gemigliptin 50mg / rosuvastatin 20mg

Group Type EXPERIMENTAL

gemigliptin 50mg, rosuvastatin 20mg

Intervention Type DRUG

gemigliptin/rosuvastatin 50/20mg

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

gemigliptin 50mg, rosuvastatin 20mg

gemigliptin/rosuvastatin 50/20mg

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Zemiglo, Cresto

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)

Minimum Eligible Age

19 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes