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.
Looking for future studies?
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.
Published trials that share one or more normalized conditions with this study.
NCT06068257
Breast Cancer, Breast Diseases
Orlando, Florida, United States
View Trial DetailsNCT06702423
Healthy
London, United Kingdom
View Trial DetailsNCT07223164
Healthy
Irvine, California, United States
View Trial DetailsNCT05595902
Healthy
Kadıköy, Istanbul, Turkey (Türkiye)
View Trial Details