BE Study of Bilayer Combination of Gemigliptin/Rosuvastatin 50/20mg in Comparison to Monolayer Combination.

March 6, 2019 updated by: LG Chem

Randomized, Open-label, Single Dose, Two-way Crossover Clinical Trial to Investigate the Pharmacokinetics/Pharmacodynamics, Safety, and Tolerability of the Monolayer Drug in Comparison to the Bilayer Drug Administered in Healthy Volunteers

To evaluate and compare PK/PD, safety and tolerability of monolayer combination of Gemigliptin/Rosuvastatin 50/20mg and bilayer combination of Gemigliprin/Rosuvastatin 50/20mg in healthy adults.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

To evaluate and compare Pharmacokinetics/Pharmacodynamics, safety and tolerability of monolayer combination of Gemigliptin/Rosuvastatin 50/20mg in comparison to bilayer combination of Gemigliprin/Rosuvastatin 50/20mg administered in healthy volunteers

Study Type

Interventional

Enrollment (Anticipated)

48

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age: 19~45
  • Body weight: 55kg or higher(female: 50kg or higher) and BMI 18~27kg/m2
  • SBP 90~150mmHg, DBP 60-95mmHg
  • Fasting glucose 70~120mg/dL

  • Infertility

    1. Surgically infertile
    2. To prevent pregnancy, participants who agreed using 2 or more contraceptive methods. Such as
  • Barrier methods: Condom, Diaphragm, Cervical cap (Pessary), Spermicide
  • Hormonal methods: Pills, Injection (Depot), Skin patch, Hormonal implant (Implanon), Vaginal ring
  • Intrauterine Devices (IUDs): Cooper IUD (Loop), Hormonal IUD (Mirena)
  • Natural methods: Basic body temperature, Ovulation period, Coitus interruptus, Abstinent
  • People who perfectly understood clinical trial and independently decided to participate in clinical trial.
  • People who will be able to collect blood sample during clinical trial period.
  • People who are suitable to participate clinical trial by physical examination, lab test and medical examination by interview.

Exclusion Criteria:

  • Genetic problems such as galactose intolerance, Lapp lacatase deficiency, glucose-galactose malabsorption
  • Clinically significant disease such as liver, kidney, digestive, pulmonary, endocrine system, cardiovascular disease etc.
  • People who have gastrointestinal disease or history of surgery which would affect absorption of drug.
  • History of clinically significant drug induced hyper-sensitive reaction or drug related muscular disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: monolayer group
monolayer of Gemigliptin/Rosuvastatin
Drug: Monolayer group
Monolayered combination of gemigliptin and rosuvastatin
Drug: Bilayer group
Bilayered combination of gemigliptin and rosuvastatin
Experimental: bilayer group
bilayer of Gemigliptin/Rosuvastatin
Drug: Monolayer group
Monolayered combination of gemigliptin and rosuvastatin
Drug: Bilayer group
Bilayered combination of gemigliptin and rosuvastatin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gemigliptin AUC
Time Frame: 0hour(pre-dose), 0.5hour, 1hour, 1.5hour, 2hour, 3hour, 4hour, 5hour, 6hour, 8hour, 12hour, 24hour, 48hour, 72hour
Gemigliptin
0hour(pre-dose), 0.5hour, 1hour, 1.5hour, 2hour, 3hour, 4hour, 5hour, 6hour, 8hour, 12hour, 24hour, 48hour, 72hour
Rosuvastain AUC
Time Frame: 0hour(pre-dose), 0.5hour, 1hour, 1.5hour, 2hour, 3hour, 4hour, 5hour, 6hour, 8hour, 12hour, 24hour, 48hour, 72hour
Rosuvastain
0hour(pre-dose), 0.5hour, 1hour, 1.5hour, 2hour, 3hour, 4hour, 5hour, 6hour, 8hour, 12hour, 24hour, 48hour, 72hour
Rosuvastain Cmax
Time Frame: 0hour(pre-dose), 0.5hour, 1hour, 1.5hour, 2hour, 3hour, 4hour, 5hour, 6hour, 8hour, 12hour, 24hour, 48hour, 72hour
Rosuvastain
0hour(pre-dose), 0.5hour, 1hour, 1.5hour, 2hour, 3hour, 4hour, 5hour, 6hour, 8hour, 12hour, 24hour, 48hour, 72hour
Gemigliptin Cmax
Time Frame: 0hour(pre-dose), 0.5hour, 1hour, 1.5hour, 2hour, 3hour, 4hour, 5hour, 6hour, 8hour, 12hour, 24hour, 48hour, 72hour
Gemigliptin
0hour(pre-dose), 0.5hour, 1hour, 1.5hour, 2hour, 3hour, 4hour, 5hour, 6hour, 8hour, 12hour, 24hour, 48hour, 72hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LG Chem

Investigators

  • Principal Investigator: kyungsang Yoo, Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 21, 2019

Primary Completion (Anticipated)

May 24, 2019

Study Completion (Anticipated)

August 31, 2019

Study Registration Dates

First Submitted

March 6, 2019

First Submitted That Met QC Criteria

March 6, 2019

First Posted (Actual)

March 8, 2019

Study Record Updates

Last Update Posted (Actual)

March 8, 2019

Last Update Submitted That Met QC Criteria

March 6, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LG-GSCL006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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