Clinical trial NCT03867942: BE Study of Bilayer Combination of Gemigliptin/Rosuvastatin 50/20mg in Comparison to Monolayer Combination.
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Diabetes Mellitus, Type 2
Dyslipidemias
Lead sponsor: LG Chem
Sponsor class: INDUSTRY
First posted: 2019-03-08
Enrollment: 48
Sex: ALL
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Gemigliptin AUC
timeFrame: 0hour(pre-dose), 0.5hour, 1hour, 1.5hour, 2hour, 3hour, 4hour, 5hour, 6hour, 8hour, 12hour, 24hour, 48hour, 72hour
measure: Rosuvastain AUC
timeFrame: 0hour(pre-dose), 0.5hour, 1hour, 1.5hour, 2hour, 3hour, 4hour, 5hour, 6hour, 8hour, 12hour, 24hour, 48hour, 72hour
measure: Rosuvastain Cmax
timeFrame: 0hour(pre-dose), 0.5hour, 1hour, 1.5hour, 2hour, 3hour, 4hour, 5hour, 6hour, 8hour, 12hour, 24hour, 48hour, 72hour
measure: Gemigliptin Cmax
timeFrame: 0hour(pre-dose), 0.5hour, 1hour, 1.5hour, 2hour, 3hour, 4hour, 5hour, 6hour, 8hour, 12hour, 24hour, 48hour, 72hour
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Seoul National University Hospital
name: kyungsang Yoo
role: PRINCIPAL_INVESTIGATOR
References: