- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04214691
A Study of Newly Formulated Tylenol Tablet (Acetaminophen) and Tylenol 8 Hour (H) Extended Release (ER) Tablet (Acetaminophen) in Healthy Participants
January 3, 2023 updated by: Janssen Korea, Ltd., Korea
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 Fed Conditions
The purpose of this study is to evaluate the bioequivalence of the newly formulated Tylenol tablet (acetaminophen 650 milligram [mg]) with respect to the Tylenol 8 hour (H) extended-release (ER) tablet (acetaminophen 650 mg) in healthy participants under fed conditions.
Study Overview
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Seoul, Korea, Republic of, 8779
- H plus Yangji Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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:
- 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
- Use of any prescription or nonprescription medication (including oriental medicines) within 30 days before the first dose of the study drug is scheduled
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment Sequence 1: Reference Drug + Test Drug (RT)
Participants will receive 8 hour (H) extended-release (ER) acetaminophen tablet orally in period 1 (Reference) followed by newly formulated acetaminophen tablet orally in period 2 (Test).
Each period will be separated by a washout period of at least 7 days.
|
Acetaminophen tablet will be administered orally in treatment sequence 1 and 2.
Other Names:
|
Experimental: Treatment Sequence 2: Test Drug + Reference Drug (TR)
Participants will receive newly formulated acetaminophen tablet orally in period 1 (Test) followed by 8H ER acetaminophen tablet orally in period 2 (Reference).
Each period will be separated by a washout period of at least 7 days.
|
Acetaminophen tablet will be administered orally in treatment sequence 1 and 2.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum Observed Analyte Concentration (Cmax)
Time Frame: Up to 24 hours post-dose
|
Cmax is the maximum observed analyte concentration.
|
Up to 24 hours post-dose
|
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).
|
Up to 24 hours post-dose
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 plasma concentration-time curve from time 0 to infinite time, calculated as the sum of AUC (0-last) and C(last)/lambda(z).
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Up to 24 hours post-dose
|
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.
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Up to 24 hours post-dose
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Time to Reach the Maximum Observed Analyte Concentration (Tmax)
Time Frame: Up to 24 hours post-dose
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Tmax is the time to reach the maximum observed analyte plasma concentration.
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Up to 24 hours post-dose
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Time to Last Measurable Plasma Concentration (T [last])
Time Frame: Up to 24 hours post-dose
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Tlast is the time to last measurable plasma concentration.
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Up to 24 hours post-dose
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Elimination Rate Constant (Lambda [z])
Time Frame: Up to 24 hours post-dose
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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.
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Up to 24 hours post-dose
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Elimination Half-Life (t 1/2)
Time Frame: Up to 24 hours post-dose
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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).
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Up to 24 hours post-dose
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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.
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Up to 41 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 17, 2019
Primary Completion (Actual)
January 16, 2020
Study Completion (Actual)
February 7, 2020
Study Registration Dates
First Submitted
December 30, 2019
First Submitted That Met QC Criteria
December 30, 2019
First Posted (Actual)
January 2, 2020
Study Record Updates
Last Update Posted (Actual)
January 5, 2023
Last Update Submitted That Met QC Criteria
January 3, 2023
Last Verified
January 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR108738
- RWJ3465PAI1002 (Other Identifier: Janssen Korea, Ltd., Korea)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency.
As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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