The purpose of this study was to determine the rate and extent of absorption of Ibuprofen suspension formulations.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
28
Reckit Benckiser
Hull, United Kingdom
Maximum Plasma Concentration (Cmax)
Time frame: Pre-dose, 10, 15, 20, 30, 40, 50, 60, 70, 80, 90, 105, 120, 180, 240, 360, 480, 720 and 1440 mins (Day 1, Post-dose)
Area Under the Plasma Concentration-time Curve From Administration to the Last Quantifiable Concentration at Time t (AUC0-t)
Time frame: Pre-dose, 10, 15, 20, 30, 40, 50, 60, 70, 80, 90, 105, 120, 180, 240, 360, 480, 720 and 1440 mins (Day 1, Post-dose)
Elimination Rate Constant (Kel)
Time frame: Pre-dose, 10, 15, 20, 30, 40, 50, 60, 70, 80, 90, 105, 120, 180, 240, 360, 480, 720 and 1440 mins (Day 1, Post-dose)
AUC From Administration to Infinity (AUC0-inf)
AUC0-inf = AUC0-t + (Ct/Kel), where Ct was the last quantifiable concentration at time t.
Time frame: Pre-dose, 10, 15, 20, 30, 40, 50, 60, 70, 80, 90, 105, 120, 180, 240, 360, 480, 720 and 1440 mins (Day 1, Post-dose)
Ratio of AUC0-t/AUC0-inf (AUCR)
Time frame: Pre-dose, 10, 15, 20, 30, 40, 50, 60, 70, 80, 90, 105, 120, 180, 240, 360, 480, 720 and 1440 mins (Day 1, Post-dose)
Time to Cmax (Tmax)
Time frame: Pre-dose, 10, 15, 20, 30, 40, 50, 60, 70, 80, 90, 105, 120, 180, 240, 360, 480, 720 and 1440 mins (Day 1, Post-dose)
Plasma Concentration Half-life (T1/2)
Terminal elimination half-life (T1/2) = ln(2)/Kel
Time frame: Pre-dose, 10, 15, 20, 30, 40, 50, 60, 70, 80, 90, 105, 120, 180, 240, 360, 480, 720 and 1440 mins (Day 1, Post-dose)
Plasma Concentration at Each Planned Nominal Time-point (Cn)
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Cn was derived using linear interpolation from the 2 samples taken either side of the nominal time where there was a sampling time deviation. For concentrations that were missing due to blood samples not being taken Cn was not derived.
Time frame: Pre-dose, 10, 15, 20, 30, 40, 50, 60, 70, 80, 90, 105, 120, 180, 240, 360, 480, 720 and 1440 mins (Day 1, Post-dose)
Number of Subjects With Adverse Events (AEs).
Intensity was determined by the Investigator. For symptomatic AEs the following definitions were applied. Mild = AE did not limit usual activities; subject may have experienced slight discomfort. Moderate = AE resulted in some limitation of usual activities; subject may have experienced significant discomfort. Severe = AE resulted in an inability to carry out usual activities; subject may have experienced intolerable discomfort/pain. Relationship to Investigational Medicinal Products (IMP) Unassessable/Unclassified = Insufficient information to be able to make an assessment. Conditional/ Unclassified = Insufficient information to make an assessment at present. Unrelated = No possibility that AE was caused by IMP. Unlikely = Slight, but remote, chance that AE was caused by IMP. Possible = Reasonable suspicion that the AE was caused by IMP. Probable = Most likely that AE was caused by IMP. Certain = AE was definitely caused by IMP.
Time frame: Up to follow-up day 7