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

Launched by SINEW PHARMA INC. · Sep 30, 2022

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ClinConnect Summary

This clinical trial is studying two different formulations of acetaminophen: Panadol® and SafeTynadol®. The goal is to see how these medications work in healthy volunteers and to evaluate the safety of SafeTynadol®, particularly its potential to cause liver damage, known as hepatotoxicity. Participants will be healthy adults aged 20 to 50, who meet specific weight and health criteria. They cannot have a history of alcohol or substance abuse, allergies to acetaminophen, or certain medical conditions that could interfere with the study.

If you decide to participate, you'll undergo a health screening to ensure you meet the eligibility requirements. During the study, you'll receive doses of either Panadol® or SafeTynadol® while the researchers monitor how your body processes these medications. It's important to know that you will need to avoid certain foods and substances, like alcohol and caffeine, around the time of dosing. This study is currently looking for volunteers, and you'll need to give your informed consent to join.

Gender

ALL

Eligibility 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.