An Open-label, One-sequence, Three-period, Multiple-dose Study to Evaluate Drug-drug Interactions, Safety and Tolerability Between NDC-002A/NDC-002B and NDC-002C in Healthy Volunteers
Overview
- Phase
- Phase 1
- Intervention
- NDC-002
- Conditions
- Stroke Sequelae
- Sponsor
- Dr. Noah Biotech Inc.
- Enrollment
- 33
- Locations
- 1
- Primary Endpoint
- Safety Evaluation: Adverse events
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
An Open-label, One-sequence, Three-period, Multiple-dose Study to Evaluate Drug-drug Interactions, Safety and Tolerability between NDC-002A/NDC-002B and NDC-002C in Healthy Volunteers
Detailed Description
This is an Open-label, One-sequence, Three-period, Multiple-dose Study and the goal of this clinical trial is to evaluate in health Volunteers. The main question\[s\] it aims to answer are: * Drug-drug Interactions * Safety * Tolerability The study consisted of Three-period: Period 1 which repeated administration of NDC-002C for 7 days and Period 2 which repeated administration of NDC-002A for 7 days, followed by administration of NDC-002B for 8 days and Period 3 which repeated concomitant administration of NDC-002B and NDC-002C for 7 days.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy adult volunteers aged between 19 and 55 at the time of screening
- •For men, those who weigh 50 kilograms or more and for women, those who weigh 45 kilograms or more and have a body mass index (BMI) between 18.0 and 30.0
- •Those who do not have any congenital or chronic disease and had no pathological symptoms or findings in a medical examination
- •Those who are deemed suitable as subjects by the investigator within four weeks prior to the first administration date of the investigational product based on the characteristics of the drug as a result of interview, physical examination, clinical laboratory test, and electrocardiogram
- •Those who are able to understand and follow instructions and participate throughout the entire clinical trial period
- •Those who agree to contraception use during the clinical trial period and can comply with medically accepted contraceptive methods (including those who are medically infertile)
- •Those who have heard and fully understood a detailed description of this clinical trial and have voluntarily decided to participate in the trial and have agreed in writing to comply with the precautions
Exclusion Criteria
- •Medical History
- •Those with or with a history of clinically significant diseases of the biliary system (biliary obstructive disease, etc.), renal system (severe renal failure, etc.), blood/oncology, cardiovascular system (congestive heart failure, coronary or aortic/mitral stenosis or complications thereof, arrhythmia, renovascular hypertension, etc.), respiratory system (asthma, chronic obstructive pulmonary disease, etc.), liver (moderate or severe liver failure, etc.), endocrine system (diabetes or impaired glucose tolerance, hypothyroidism, primary aldosteronism, etc.), digestive system, musculoskeletal system, or central nervous system disease (Parkinson's disease, etc.), or mental illness or malignant tumor
- •Those with a history of gastrointestinal disease (Crohn's disease, ulcers, gastritis, gastrospasms, gastroesophageal reflux, acute or chronic pancreatitis, etc.) or gastrointestinal surgery (except simple appendectomy or hernia surgery) that may affect drug absorption
- •Those with a history of hypersensitivity or clinically significant hypersensitivity to donepezil or drugs containing NAC or similar agents (piperidine derivatives, etc.), or other drugs (aspirin, antibiotics, etc.)
- •Those who have suffered from a clinically significant disease within 30 days before the first administration of the investigational product
- •Clinical Laboratory Tests
- •Those with systolic blood pressure ≥ 140 mmHg or ≤ 99 mmHg, or diastolic blood pressure ≥ 91 mmHg or ≤ 59 mmHg, or measured pulse rate ≥ 101 or ≤ 40 times per minute for vital signs measured in a sitting position after sufficient rest
- •Those who are tested positive for serological tests (hepatitis B, hepatitis C, syphilis, HIV)
- •Patients with active liver disease, including a persistent increase of liver enzyme levels (AST, ALT) of unknown etiology or an increase of liver enzyme levels ≥ 1.5 times the ULN
- •Patients with renal impairment of moderate or higher renal failure (GFR \<60 mL/min based on the Cockcroft-Gault method)
Arms & Interventions
NDC-002
In Period 1, Two tablets of NDC-002C are repeatedly administered once a day for seven days to reach a steady state of NDC-002C. There is a seven-day washout period between Period 1 and Period 2. In Period 2, after repeated administration of one tablet of NDC-002A once a day for seven days, one tablet of NDC-002B is administered repeatedly once a day for eight days to reach a steady state of NDC-002B. In Period 3, after the completion of Period 2 administration and without a washout period, one tablet of NDC-002B and two tablets of NDC-002C administered repeatedly in combination once a day for seven days.
Intervention: NDC-002
Outcomes
Primary Outcomes
Safety Evaluation: Adverse events
Time Frame: Up to 10 days post final dose
Subjective/objective symptoms
Pharmacokinetic Evaluation: AUCss,τ of NDC-002B/C
Time Frame: Day 1, Day 7, Day15, Day 29, Day 36
after single and concomitant administration of NDC-002B/C
Pharmacokinetic Evaluation: Css,max of NDC-002B/C
Time Frame: Day 1, Day 7, Day15, Day 29, Day 36
after single and concomitant administration of NDC-002B/C
Secondary Outcomes
- Pharmacokinetic Evaluation: AUCss,inf of NDC-002B/C(Day 1, Day 7, Day15, Day 29, Day 36)
- Pharmacokinetic Evaluation: Tss,max of NDC-002B/C(Day 1, Day 7, Day15, Day 29, Day 36)
- Pharmacokinetic Evaluation: Tss,1/2 of NDC-002B/C(Day 1, Day 7, Day15, Day 29, Day 36)