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 Various Formulations of SafeTynadol® in Healthy Volunte

• Status: Not yet recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

Summary

To investigate and compare the possible response of Panadol® and SafeTynadol® formulations in healthy volunteers and the safety in SafeTynadol® dose-limiting hepatotoxicity.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Sinew Pharma Inc.
• Treatments: Acetaminophen

Criteria

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.