Hepatitis Clinical Trial
Official title:
A Partial Randomized, Single-blind or Open-label, Dose-escalation With Multiple-dose Design Study to Evaluate the Pharmacokinetics of Acetaminophen and Its Toxic Metabolites With Panadol® and SafeTynadol® in Healthy Volunteers
To investigate and compare the possible response of Panadol® and SafeTynadol® formulations in healthy volunteers and the safety in SafeTynadol® dose-limiting hepatotoxicity.
Status | Recruiting |
Enrollment | 48 |
Est. completion date | December 2024 |
Est. primary completion date | June 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 20 Years to 50 Years |
Eligibility | Inclusion Criteria: - Normal healthy adult subjects between 20-50 years of age. - Body weight within 80-120% of ideal body weight. - Male Ideal body weight = (height - 80) x 0.7 - Female Ideal body weight = (height - 70) x 0.6 - Acceptable medical history and physical examination including: - normal ECG results within six months prior to dosing. - no particular clinical significance in general disease history within two months prior to dosing. - Acceptable clinical laboratory determinations without significant deviation from normal values within two months prior to dosing, which includes AST (SGOT), ALT (SGPT), r-GT, alkaline phosphatase, total bilirubin, albumin, glucose, BUN, uric acid, creatinine, total cholesterol, triglyceride (TG), PT(INR) and OGSP. - Acceptable hematology within two months prior to dosing, which includes hemoglobin, hematocrit, red blood cells, MCV, MCH, MCHC, white blood cells, differential white blood cells and platelets. - Acceptable urinalysis within two months prior to dosing, which includes pH, blood, glucose and protein. - Signed the written informed consent to participate in this study Exclusion Criteria: - History or presence of alcohol abuse, defined as consumption of more than 210 mL of alcohol per week (the equivalent of 14 glasses of 120-mL wine or 14 cans of 350-mL beer), or other substance abuse within the prior two years. - A clinically significant disorder involving the allergy, cardiovascular, respiratory, renal, gastrointestinal/hepatic, immunologic, hematologic, endocrine or neurologic system(s) or psychiatric disease (as determined by the clinical investigator). - History of allergic response(s) to acetaminophen, mannitol, sucralose or related drugs. - History of clinically significant allergies including drug allergies or allergic bronchial asthma. - Evidence of chronic or acute infectious diseases. - Any clinically significant illness or surgery during the two month prior to dosing (as determined by the clinical investigator). - Taking any drug known to induce or inhibit hepatic drug metabolism within one month prior to the beginning of the study. - Receiving any investigational drug within one month prior to dosing. - Taking any prescription medication or any nonprescription medication within two weeks prior to dosing. - Donating greater than 150 ml of blood within two months prior to dosing or donating plasma (e.g. plasmapheresis) within two weeks prior to dosing. - Consumption of caffeine, xanthine-containing products (i.e. coffee, tea, caffeine-containing sodas, colas and chocolate, etc.) and/or alcohol within 48 hours prior to days on which dosing is scheduled and during the periods when blood samples are being collected. - Any other medical reason as determined by the clinical investigator. - Subject is pregnant or breastfeeding. - Women of childbearing potential disagree to use an acceptable method of contraception (e.g., hormonal contraceptives, intrauterine device (IUD), barrier device or abstinence) throughout the study. |
Country | Name | City | State |
---|---|---|---|
Taiwan | Tri-Service General Hospital | Taipei City | Neihu District |
Lead Sponsor | Collaborator |
---|---|
Sinew Pharma Inc. |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | ALT level within study periods | Day 1-9 | ||
Secondary | Incidence of peak ALT elevations > 1X ULN within study periods | Day 1-9 | ||
Secondary | Incidence of peak ALT elevations > 2X ULN within study periods | Day 1-9 | ||
Secondary | Incidence of peak ALT elevations > 3X ULN within study periods | Day 1-9 | ||
Secondary | Incidence of peak ALT elevations > 5X ULN within study periods | Day 1-9 | ||
Secondary | Incidence of peak ALT elevations > 8X ULN within study periods | Day 1-9 | ||
Secondary | Incidence of total bilirubin > 2.5mg/dL within study periods | Day 1-9 | ||
Secondary | Incidence of PT (INR) > 1.25 within study periods | Day 1-9 | ||
Secondary | Hepatic failure rate | Hepatic failure rate (hepatic encephalopathy, ascites, total bilirubin >2.5mg/dL, PT(INR) >1.25 , or liver transplantation) within study periods | Day 1-9 | |
Secondary | Free plasma acetaminophen-cysteine (AAP-Cys) and AAP-Cys adducts | The time-interval weighted area under the curve (AUC) of free plasma acetaminophen-cysteine (AAP-Cys) and AAP-Cys adducts within study periods | Day 1-9 | |
Secondary | The time-interval weighted area under the curve (AUC) of ALT level within study periods | Day 1-9 |
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