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

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ClinicalTrials.gov Identifier: NCT04214691
Recruitment Status : Active, not recruiting
First Posted : January 2, 2020
Last Update Posted : February 11, 2020
Sponsor:
Information provided by (Responsible Party):
Janssen Korea, Ltd., Korea

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Acetaminophen Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official 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 Fed Conditions
Actual Study Start Date : December 17, 2019
Actual Primary Completion Date : January 16, 2020
Estimated Study Completion Date : February 14, 2020

Resource links provided by the National Library of Medicine


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.
Drug: Acetaminophen
Acetaminophen tablet will be administered orally in treatment sequence 1 and 2.
Other Name: Tylenol

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.
Drug: Acetaminophen
Acetaminophen tablet will be administered orally in treatment sequence 1 and 2.
Other Name: Tylenol




Primary Outcome Measures :
  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 Outcome Measures :
  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 plasma 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 plasma 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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:

  • 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

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): NCT04214691


Locations
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Korea, Republic of
H plus Yangji Hospital
Seoul, Korea, Republic of, 08779
Sponsors and Collaborators
Janssen Korea, Ltd., Korea
Investigators
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Study Director: Janssen Korea, Ltd., Korea Clinical Trial Janssen Korea, Ltd., Korea

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Responsible Party: Janssen Korea, Ltd., Korea
ClinicalTrials.gov Identifier: NCT04214691    
Other Study ID Numbers: CR108738
RWJ3465PAI1002 ( Other Identifier: Janssen Korea, Ltd., Korea )
First Posted: January 2, 2020    Key Record Dates
Last Update Posted: February 11, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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

URL: https://www.janssen.com/clinical-trials/transparency

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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