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

Lead sponsor

Janssen Korea, Ltd., Korea is the lead sponsor of 75 studies on the registry; 2 are open to participants now.

Study arms

• 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

• Experimental
  Treatment Sequence 2: Test Drug + Reference Drug (TR)

  Participants will receive newly formulated acetaminophen tablet orally in period 1 (Test) followed by 8 hour ER acetaminophen tablet orally in period 2 (Reference). Each period will be separated by a washout period of at least 7 days.

  Drug: Acetaminophen

Interventions

• DrugAcetaminophen

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

  Also known as: Tylenol, JNJ-28678-AAA

Primary outcomes

1. Maximum Observed Analyte Concentration (Cmax)

   Cmax is the maximum observed analyte concentration.

   Time frame: Up to 24 hours post-dose

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

   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).

   Time frame: Up to 24 hours post-dose

Secondary outcomes

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

   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).

   Time frame: Up to 24 hours post-dose

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

   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.

   Time frame: Up to 24 hours post-dose

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

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

   Time frame: Up to 24 hours post-dose

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

   Tlast is the time to last measurable plasma concentration.

   Time frame: Up to 24 hours post-dose

5. Elimination Rate Constant (Lambda [z])

   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.

   Time frame: Up to 24 hours post-dose

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

   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).

   Time frame: Up to 24 hours post-dose

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

   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.

   Time frame: Up to 41 days

Individual participant data

Plan to share: Yes — 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