Effect of Tegoprazan or RAPA114 on Pharmacokinetic of Atorvastatin in Healthy Adult Volunteers
NCT ID: NCT04221321
Last Updated: 2020-12-01
Study Results
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.
COMPLETED
PHASE1
32 participants
INTERVENTIONAL
2020-01-07
2020-04-20
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* Primary outcome: AUCτ, Css,max of atorvastatin
* Secondary outcome: Tss,max of atorvastatin, AUCτ, Css,max of 2-OH atorvastatin, metabolic ratio
\[Sefety Assessments\]
: Safety assessments with adverse event monitoring including subjective/objective symptoms, physical examination, vital signs, electrocardiogram, and laboratory test
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Atorvastatin 40 mg
Oral administration of Atorvastatin 40 mg tablet once daily for 7 days
Atorvastatin 40 mg
Atorvastatin 40 mg
Atorvastatin 40 mg + Tegoprazan 50 mg
Oral administration of Atorvastatin 40 mg tablet and Tegoprazan 50 mg tablet once daily for 7 days
Atorvastatin 40 mg
Atorvastatin 40 mg
Tegoprazan 50 mg
Tegoprazan 50 mg tablet
Atorvastatin 40 mg + RAPA114
Oral administration of Atorvastatin 40 mg tablet and RAPA114 tablet once daily for 7 days
Atorvastatin 40 mg
Atorvastatin 40 mg
RAPA114
RAPA114 tablet
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Atorvastatin 40 mg
Atorvastatin 40 mg
Tegoprazan 50 mg
Tegoprazan 50 mg tablet
RAPA114
RAPA114 tablet
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Body mass index (BMI) ≥ 19.0 and ≤ 27.0 kg/m2 at screening.
* Decides to participate voluntarily in the trial after being fully informed of and understanding the study completely, and provides the written informed consent to participate in the trial and to comply with the trial-specific requirements.
* Has the ability and willingness to participate in the entire period of clinical trial.
Exclusion Criteria
* A subject with a history of hypersensitivity reactions to main constituents of or identical affiliation of the investigational products (ex, HMG-CoA reductase inhibitor, gastric acid suppressants), or have allergic diseases that require treatment.
* A subject with a history of genetic myopathy or family history.
* A subject who has participated in other clinical trials and received the investigational products within 180 days prior to the randomization.
* A subject who received any medications or foods that could significantly affect the absorption, distribution, metabolism, or excretion of an investigational product within 30 days prior to the randomization.
* A subject with history of whole blood donation within 60 days, or with blood components or received transfusion within 30 days prior to the randomization.
* A subject with continued consumption of alcohol more than 140 g per week.
* A subject with AST, ALT, or γ-GT levels exceeding 1.5 times of the upper limit of the reference range in the screening test.
* A subject with a calculated glomerular filtration rate of less than 60 mL / min / 1.73 m2 in the screening test.
* A subject with any positive result on serology tests for hepatitis B, hepatitis C, HIV or syphilis in the screening test.
* A subject with galactose intolerance, Lapp lactose dehydrogenase deficiency or glucose-galactose malabsorption, etc.
* Male subject who don't have willing to accept medically acceptable contraceptive methods during the course of clinical trial, or who plan to provide sperm.
* A subject who is determined to be ineligible to participate in the clinical trial by the investigator for other reasons.
19 Years
55 Years
MALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
HK inno.N Corporation
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jung-ryul Kim
Role: PRINCIPAL_INVESTIGATOR
Samsung Medical Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Samsung Medical Center
Seoul, , South Korea
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IN_APA_114
Identifier Type: -
Identifier Source: org_study_id