A Study to Evaluate the Pharmacokinetics of Acetaminophen and Its Toxic Metabolites With 2 Formulations (Panadol and SafeTynadol) in Healthy Volunteers

• Status: Completed
• Trial end date: 2016-02-01
• Target enrollment: 0
• Participant gender: All

Summary

To investigate and compare the possible response of Panadol® and SafeTynadol® formulations in healthy volunteers.

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

Details

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

Criteria

Inclusion Criteria:

1. healthy adult subjects between 20-50 years of age.

2. 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

3. Acceptable medical history and physical examination including:

• normal ECG results within six months prior to Period I dosing.

• no particular clinical significance in general disease history within two months prior to Period I dosing.

4. Acceptable clinical laboratory determinations without significant deviation from normal values within two months prior to Period I dosing, which includes AST (SGOT), ALT (SGPT), g-GT, alkaline phosphatase, total bilirubin, albumin, glucose, BUN, uric acid, creatinine, total cholesterol, triglyceride (TG) and galactose single point (GSP).

5. Acceptable hematology within two months prior to the study, which includes hemoglobin, hematocrit, red blood cells, MCV, MCH, MCHC, white blood cells, differential white blood cells and platelets.

6. Acceptable urinalysis within two months prior to the study, which includes pH, blood, glucose and protein.

7. Signed the written informed consent to participate in this study.

Exclusion Criteria:

1. Recent history of drug or alcohol addiction or abuse within the past year.

2. A clinically significant disorder involving the cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic, endocrine or neurologic system(s) or psychiatric disease (as determined by the clinical investigator).

3. History of allergic response(s) to acetaminophen, mannitol, sucralose or related drugs.

4. History of clinically significant allergies including drug allergies or allergic bronchial asthma.

5. Evidence of chronic or acute infectious diseases.

6. Any clinically significant illness or surgery during the one month prior to Period I dosing (as determined by the clinical investigator).

7. Taking any drug known to induce or inhibit hepatic drug metabolism within one month prior to the beginning of the study.

8. Receiving any investigational drug within one month prior to Period I dosing.

9. Taking any prescription medication or any nonprescription medication within two weeks prior to Period I dosing.

10. Donating greater than 150 ml of blood within two months prior to Period I dosing or donating plasma (e.g. plasmapheresis) within two weeks prior to Period I dosing. All subjects will be advised not to donate blood for four weeks after completing the study.

11. 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.

12. Any other medical reason as determined by the clinical investigator.

13. Subject is pregnant or breastfeeding.

14. Women of childbearing potential disagree to use an acceptable method of contraception (e.g., hormonal contraceptives, IUD, barrier device or abstinence) throughout the study.

Note: Sponsor clarified the terms "prior to Period I dosing" described in inclusion criteria and exclusion criteria meant "prior to Period III dosing" in high dose stage.