H plus Yangji Hospital
Seoul, 8779, South Korea
NCT Number: NCT04230252
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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Notify Me19 year and older
All sexes
Interventional
Phase 1
Seoul, 8779, South Korea
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Acetaminophen tablet will be administered orally in treatment sequence 1 and 2.
Other names: Tylenol, JNJ-28678-AAA
Time frame: Up to 24 hours post-dose
Cmax is the maximum observed analyte concentration.
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).
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).
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.
Time frame: Up to 24 hours post-dose
Tmax is the time to reach the maximum observed analyte concentration.
Time frame: Up to 24 hours post-dose
Tlast is the time to last measurable plasma concentration.
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.
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).
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.
Janssen Korea, Ltd., Korea
Industry
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
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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