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Completed

NCT Number: NCT04230252

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

The purpose of this study is to evaluate the bioequivalence of the newly formulated Tylenol tablet (acetaminophen 650 mg) with respect to the Tylenol 8 Hour (H) Extended Release (ER) tablet (acetaminophen 650 mg) in healthy participants under fasting conditions.

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Key information

Conditions

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

H plus Yangji Hospital

Seoul, 8779, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acetaminophen

Drug

Acetaminophen tablet will be administered orally in treatment sequence 1 and 2.

Other names: Tylenol, JNJ-28678-AAA

Primary outcomes

  1. Maximum Observed Analyte Concentration (Cmax)

    Time frame: Up to 24 hours post-dose

    Cmax is the maximum observed analyte concentration.

  2. Area Under the Concentration-time Curve From Time 0 to Time of the Last Measurable Concentration (AUC [0-last])

    Time frame: Up to 24 hours post-dose

    AUC (0-last) is the area under the concentration-time curve from time 0 to time of the last measurable concentration (non-below quantitation limit).

Secondary outcomes

  1. Area Under the Concentration-time Curve From Time 0 to Infinite Time (AUC[0-infinity])

    Time frame: Up to 24 hours post-dose

    AUC(0-infinity) is the area under the concentration-time curve from time 0 to infinite time, calculated as the sum of AUC (0-last) and C(last)/lambda(z).

  2. Percentage of Area Under the Concentration-time Curve Extrapolated from Last Measurable Concentration to Infinite Time (Extrapolated %AUCinfinity)

    Time frame: Up to 24 hours post-dose

    Percentage of area under the concentration-time curve extrapolated from last measurable concentration to infinite time (extrapolated %AUCinfinity) is calculated using formula: (AUC [0-infinity] minus AUC [0-last]/AUC [0-infinity])*100.

  3. Time to Reach the Maximum Observed Analyte Concentration (Tmax)

    Time frame: Up to 24 hours post-dose

    Tmax is the time to reach the maximum observed analyte concentration.

  4. Time to Last Measurable Plasma Concentration (T [last])

    Time frame: Up to 24 hours post-dose

    Tlast is the time to last measurable plasma concentration.

  5. Elimination Rate Constant (Lambda [z])

    Time frame: Up to 24 hours post-dose

    Lambda (z) is the apparent terminal elimination rate constant determined by linear regression using the terminal log-linear phase of the log transformed concentration-time curve.

  6. Elimination Half-Life (t 1/2)

    Time frame: Up to 24 hours post-dose

    t1/2 is defined as apparent is associated terminal elimination half-life associated with the terminal slope (lambda [z]) of the semilogarithmic drug concentration-time curve, calculated as: 0.693/lambda(z).

  7. Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability

    Time frame: Up to 41 days

    An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.

Sponsors and collaborators

Lead sponsor

Janssen Korea, Ltd., Korea

Industry

Registry information

Official study title

A Single-dose, Open-label, Randomized, Two-treatment, Two-period, Crossover Study in Healthy Subjects to Assess the Bioequivalence of the Newly Formulated Tylenol® Tablet (Acetaminophen) to the Tylenol® 8H ER Tablet (Acetaminophen) Under Fasting Conditions

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jan 18, 2020
Registry last updated
Apr 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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