Clinical trial: A Study of the Newly Formulated Tylenol Tablet (Acetaminophen) to the Tylenol 8 Hour (H) Extended Release (ER) Tablet (Acetaminophen) in Healthy Participants (NCT04230252)

Eligibility criteria:
Inclusion Criteria:

          -  Healthy on the basis of physical examination, medical history, vital signs, and
             12-lead electrocardiogram (ECG) performed at screening. If there are abnormalities,
             they must be consistent with the underlying illness in the study population. This
             determination must be recorded in the participant's source documents

          -  Healthy on the basis of clinical laboratory tests performed at screening. If the
             results of the serum chemistry panel including liver enzymes, other specific tests,
             hematology, urinalysis or breathing alcohol test are outside the normal reference
             ranges, the participant may be included only if the investigator judges the
             abnormalities or deviations from normal to be not clinically significant. This
             determination must be recorded in the participant's source documents and initialed by
             the investigator

          -  Blood pressure (after the participant is sitting for 5 minutes) between 90 and 140
             millimeters of Mercury (mmHg) systolic, inclusive, and no higher than 90 mmHg
             diastolic

          -  Have no history of psychiatric disorder within the 5 years prior to the screening

          -  Have no history of gastrointestinal resection that may affect drug absorption

        Exclusion Criteria:

          -  History of or current clinically significant medical illness including (but not
             limited to) cardiac arrhythmias or other cardiac disease, hematologic disease,
             coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid
             abnormalities, significant pulmonary disease, including bronchospastic respiratory
             disease, diabetes mellitus, hepatic or renal insufficiency (creatinine clearance below
             60 milliliter per minute [mL/min]), thyroid disease, neurologic or psychiatric
             disease, infection, or any other illness that the investigator considers should
             exclude the participant or that could interfere with the interpretation of the study
             results

          -  Clinically significant abnormal physical examination, vital signs, or 12 lead ECG at
             screening as deemed appropriate by the investigator

          -  Known allergies, hypersensitivity, or intolerance to acetaminophen or its excipients

          -  History of malignancy within 5 years before screening (exceptions are squamous and
             basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy,
             which is considered cured with minimal risk of recurrence)

          -  Taken any disallowed therapies as noted in local prescribing information, concomitant
             therapy before the planned first dose of study drug
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 19 Years old.


Patient description (medical language): The patient is a 38-year-old man with cough and body ache that started 3 days ago.  He had fever and chills at the beginning and has low grade fever at the time of visit. He feels tired and sleepy. His body ache and myalgia get better after using Tylenol. The PCR test for Covid is positive. His vital signs are within normal limits with a body temperature of 37.9 C. There is no lymphadenopathy or white exudates in the pharynx.

Patient description (patient's own words): I was feeling really sick the other day, to the point that I showed up at the doctor's office. I was coughing, and my body was hurting for 3 days. I had a fever and chills and felt tired and sleepy. I got better after using Tylenol. They did a PCR Covid test on me, and it was positive! My vitals were normal, and my temperature was 37.9 C. I had no swelling around my neck or white spots on the back of my throat.

Does the patient match the trial criteria? Contradiction