Effect of Tegoprazan or RAPA114 on Pharmacokinetic of Atorvastatin in Healthy Adult Volunteers
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Registration Number
- NCT04221321
- Lead Sponsor
- HK inno.N Corporation
- Brief Summary
This study aims to evaluate the influence of tegoprazan or RAPA114 on the Pharmacokinetic characteristics of atorvastatin following co-administration of tegoprazan or RAPA114 in healthy adult volunteers.
- Detailed Description
\[Pharmacokinetic Assessments\] : Blood concentration of atorvastatin, 2-OH atorvastatin
* 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 32
Inclusion Criteria
- Healthy male adults aged 19 to 55 years (inclusive) at the time of his consent.
- 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 clinically significant disease or history of hepatobiliary, renal, gastrointestinal, cardiovascular, musculoskeletal, endocrine, respiratory, neuropsychiatry or hemato-oncologic system, etc.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Atorvastatin 40 mg + RAPA114 Atorvastatin 40 mg Oral administration of Atorvastatin 40 mg tablet and RAPA114 tablet once daily for 7 days Atorvastatin 40 mg + Tegoprazan 50 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 Oral administration of Atorvastatin 40 mg tablet once daily for 7 days Atorvastatin 40 mg + Tegoprazan 50 mg Atorvastatin 40 mg Oral administration of Atorvastatin 40 mg tablet and Tegoprazan 50 mg tablet once daily for 7 days Atorvastatin 40 mg + RAPA114 RAPA114 Oral administration of Atorvastatin 40 mg tablet and RAPA114 tablet once daily for 7 days
- Primary Outcome Measures
Name Time Method AUCτ of atorvastatin Pre-dose on Day 1,5,6,7 and post-dose up to 24 hours on Day 7 in each period Area under the plasma drug concentration-time curve at steady state
Css,max of atorvastatin Pre-dose on Day 1,5,6,7 and post-dose up to 24 hours on Day 7 in each period Maximum concentration of drug in plasma of atorvastatin at steady state
- Secondary Outcome Measures
Name Time Method AUCτ of 2-OH atorvastatin Pre-dose on Day 1,5,6,7 and post-dose up to 24 hours on Day 7 in each period Area under the plasma drug concentration-time curve at steady state
Css,max of 2-OH atorvastatin Pre-dose on Day 1,5,6,7 and post-dose up to 24 hours on Day 7 in each period Maximum concentration of drug in plasma of 2-OH atorvastatin at steady state
Tss,max of atorvastatin Pre-dose on Day 1,5,6,7 and post-dose up to 24 hours on Day 7 in each period Time to Cmax at steady state
metabolic ratio Pre-dose on Day 1,5,6,7 and post-dose up to 24 hours on Day 7 in each period AUCτ of 2-OH atorvastatin / AUCτ of atorvastatin
Trial Locations
- Locations (1)
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center🇰🇷Seoul, Korea, Republic of