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Trial record 3 of 1876 for:    Acetaminophen

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

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ClinicalTrials.gov Identifier: NCT03451487
Recruitment Status : Completed
First Posted : March 1, 2018
Last Update Posted : March 1, 2018
Sponsor:
Information provided by (Responsible Party):
Sinew Pharma Inc.

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

Condition or disease Intervention/treatment Phase
Acetaminophen Toxicity Drug: Panadol® Drug: SafeTynadol® Phase 1

Detailed Description:
Acetaminophen (AAP) is the most popular used analgesic/ antipyretic drug with serious hepatotoxic adverse effects; suicidal or unintentional overdose of AAP-induced hepatotoxicity. Cytochrome P450 2E1 (CYP2E1) is thought contribute to the responsible reactive metabolite N-acetyl-p-benzoquinone (NAPQI) of AAP overdose-induced hepatotoxicity. Pharmaceutical excipients are inactive ingredients that are added to a pharmaceutical compound. The objective of this study was to investigate the possible response of Panadol® (AAP alone) and SafeTynadol® (AAP with various selected excipients combination) formulations, while observing the AAP toxic metabolites (AAP-Cys) circumstances change in healthy volunteers. According to the current safety data, could be potentially develop hepatotoxicity-free AAP new formulation drug.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Randomized, Open-label, Single Dose, Crossover Design Phase I Study to Evaluate the Pharmacokinetics of Acetaminophen and Its Toxic Metabolites With 2 Formulations (Panadol and SafeTynadol) in Healthy Volunteers
Actual Study Start Date : September 2015
Actual Primary Completion Date : September 2015
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Reference drug (1000mg)

Eligible subjects were randomly assigned to either of the two treatment sequence.The evaluable subjects were those who had completed both period I and II. The study was completed when there were at least 12 evaluable subjects.

Panadol® oral dosage form (500 mg*2 tablets = 1000 mg) was orally administered with 240 ml of water once daily in the morning in each of the single-dose study period.

Drug: Panadol®
Acetaminophen 500mg Tablet
Other Name: Acetaminophen

Experimental: Test drug (1000mg)

Eligible subjects were randomly assigned to either of the two treatment sequence.The evaluable subjects were those who had completed both period I and II. The study was completed when there were at least 12 evaluable subjects.

SafeTynadol® oral dosage form (500 mg*2 tablets = 1000 mg) was orally administered with 240 ml of water once daily in the morning in each of the single-dose study period.

Drug: SafeTynadol®
Acetaminophen 500mg Tablet
Other Name: SNP-810

Placebo Comparator: Reference drug (4000mg)

Eligible subjects were randomly assigned to either of the two treatment sequence.The evaluable subjects were those who had completed both period III and IV. The study was completed when there were at least 12 evaluable subjects.

Panadol® oral dosage form (500 mg*8 tablets = 4000 mg) was orally administered with 240 ml of water once daily in the morning in each of the single-dose study period.

Drug: Panadol®
Acetaminophen 500mg Tablet
Other Name: Acetaminophen

Experimental: Test drug (4000mg)

Eligible subjects were randomly assigned to either of the two treatment sequence.The evaluable subjects were those who had completed both period III and IV. The study was completed when there were at least 12 evaluable subjects.

SafeTynadol® oral dosage form (500 mg*8 tablets = 4000 mg) was orally administered with 240 ml of water once daily in the morning in each of the single-dose study

Drug: SafeTynadol®
Acetaminophen 500mg Tablet
Other Name: SNP-810




Primary Outcome Measures :
  1. Blood concentration of SafeTynadol [ Time Frame: PK samples were collected at pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hours post dose (a total of 13 samples per subject in each period). ]
    Concentrations of acetaminophen and it metabolites (AAP-Glc、AAP-Sul、GS-Catechol、GS-AAP、AAP-Cys、AAP-NAC) in plasma will be measured by a specific and sensitive LC/MS/MS method developed in the laboratory of Clinical Pharmacokinetic Laboratory of Tri-Service General Hospital. According to the pharmacokinetic parameters of AAP and its metabolites in health subjects oral Panadol® (AAP alone) and SafeTynadol (AAP with various selected excipients combinations) to assess the safety information. The study will be conducted to validate the precision, accuracy (including with-run and between-run variation), linearity, specificity, reproducibility, limit of quantitation based on recovery studies. Assays will be performed in the laboratory of Clinical Pharmacokinetic Laboratory of Tri-Service General Hospital. Spiked samples of known concentrations will be analyzed together for quality control of the assay method.



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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03451487


Locations
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Taiwan
Tri-Service General Hospital
Taipei, Taiwan
Sponsors and Collaborators
Sinew Pharma Inc.

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Responsible Party: Sinew Pharma Inc.
ClinicalTrials.gov Identifier: NCT03451487     History of Changes
Other Study ID Numbers: TSGHIRB No.2-104-01-011
First Posted: March 1, 2018    Key Record Dates
Last Update Posted: March 1, 2018
Last Verified: February 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Sinew Pharma Inc.:
acetaminophen
acute liver failure
Additional relevant MeSH terms:
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Acetaminophen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics