Mode
Text Size
Log in / Sign up
Phase 1 Completed N=84 Randomized Other

A Bioequivalence Study of Two Ibuprofen Arginine Granules 400 mg Formulations Under Fasting and Fed Conditions in Chinese Healthy Adult Subjects

Source: ClinicalTrials.gov NCT05737069 ↗
Enrolled (actual)
84
Serious AEs
0.0%
Results posted
Sep 2024
Primary outcomePrimary: Area Under the Plasma Concentration Time Curve From Time Zero to Last Observed Concentration at Time t (AUC[0-t]) for Ibuprofen in Fasted Conditions — 122.2406; 122.1489 hour*micrograms per milliliter

Summary

The primary purpose of this study is to demonstrate the bioequivalence of two ibuprofen arginine granules 400 milligram (mg) formulations under fasting and fed conditions in Chinese healthy adult participants. The secondary purpose of this study is to assess the pharmacokinetic and safety profile of the test and reference preparations.

Outcome Measures

OutcomeResultp-value
PRIMARY
Area Under the Plasma Concentration Time Curve From Time Zero to Last Observed Concentration at Time t (AUC[0-t]) for Ibuprofen in Fasted Conditions
122.2406; 122.1489
PRIMARY
Area Under the Plasma Concentration Time Curve From Time Zero to Time Infinity (AUC [0-inf]) for Ibuprofen in Fasted Conditions
124.8000; 124.5173
PRIMARY
Observed Maximum Plasma Concentration (Cmax) for Ibuprofen in Fasted Conditions
54.400; 55.368
PRIMARY
AUC(0-t) for Ibuprofen in Fed Conditions
114.2490; 115.2125
PRIMARY
AUC (0-inf) for Ibuprofen in Fed Conditions
125.0559; 128.9471
PRIMARY
Cmax for Ibuprofen in Fed Conditions
17.8260; 17.8573
SECONDARY
Time to Reach Maximum Plasma Concentration (Tmax) of Ibuprofen in Fasted Conditions
0.330; 0.330
SECONDARY
Elimination Half-life (t1/2) of Ibuprofen in Fasted Conditions
2.2023; 2.1300
SECONDARY
Terminal Elimination Rate Constant (λz) of Ibuprofen in Fasted Conditions
0.3155; 0.3212
SECONDARY
Percentage of Extrapolated Area of AUC(0-inf) (%AUCex) of Ibuprofen in Fasted Conditions
1.8299; 1.7393
SECONDARY
Tmax of Ibuprofen in Fed Conditions
4.500; 4.500
SECONDARY
t1/2 of Ibuprofen in Fed Conditions
2.4053; 2.3995
SECONDARY
λz of Ibuprofen in Fed Conditions
0.2653; 0.2515
SECONDARY
%AUCex of Ibuprofen in Fed Conditions
7.9436; 8.3506

Eligibility Criteria

Inclusion Criteria

  • Participants provision of a signed and dated informed consent and/or assent document indicating that the participant has been informed of all pertinent aspects of the study before any assessment is performed.
  • Participants who is willing and able to comply with scheduled visits, treatment plan, laboratory tests, study restrictions, lifestyle considerations and other study procedures.
  • Healthy Participants, which is defined as in general good physical health, as judged by the investigator and no clinically significant relevant abnormalities identified by a detailed medical history, full physical examination, including vital signs, 12-lead electrocardiogram (ECG) and laboratory tests.
  • A Participants with a Body Mass Index (BMI) of 19-26 kilogram per meter square (kg/m^2) (including 19, excluding 26) [BMI equal to (=) weight (Kilogram [kg])/height^2 (m^2)]; and a total body weight more than or equal to >= 50 kilogram (kg) for males, and >= 45 kg for females, at screening.
  • Participants with one negative polymerase chain reaction (PCR) or antigen test (on Day-1) for active Coronavirus disease 2019 (COVID-19).
  • Participants of childbearing potential and are sexually active and at risk for pregnancy must agree to use a highly effective method of contraception throughout the study and for at least 30 days after the last dose of assigned treatment. Female participant who are not of childbearing potential must meet requirements in the Contraception section of protocol.

Exclusion Criteria

  • Known or suspected intolerance or hypersensitivity or photosensitivity to the investigational products (or closely related compounds) or any of their stated ingredients.
  • Allergy to skin disinfecting agents, tape, or latex rubber, whenever appropriate substitutions cannot be applied or in the investigator's opinion may pose a risk to the candidate.
  • Diagnosis of long QT syndrome or QTcF > 450 millisecond (msec) at screening.
  • Clinically significant vital sign abnormalities (systolic blood pressure lower than 90 or over 140 millimeters of mercury (mmHg), diastolic blood pressure lower than 60 or over 90 mmHg, or pulse rate less than 50 or over 100 beats per minute [bpm]).
  • Use of any medication (including over-the-counter medications and Chinese herbal and traditional remedies) within 2 weeks before first scheduled study drug administration or within less than 10 times the elimination half-life of the concomitant medication (whichever is longer) or is anticipated to require any concomitant medication during that period or at any time throughout the study. Allowed treatments are:
  • systemic contraceptives and hormone replacement therapy, as long as female participant is on stable treatment for at least 3 months before first scheduled study drug administration and continues treatment throughout the study.
  • occasional use of acetaminophen (up to 2 grams [g] in 24 hours).
  • Participants has a history of drug abuse or has positive urine drug abuse screening at screening or on Day-1.
  • Participants reported regular consumption of > 5 cups (1 cup approximately 250 milliliters [mL]) of coffee or tea per day (or equivalent consumption of >= 500 mg caffeine per day using other products). Or consuming any beverages or food containing caffeine, such as coffee, tea, coke, chocolate, etc., within 48 hours prior to screening.
  • Smoking or history of regular use of tobacco- or nicotine-containing products (for example nicotine patch, electronic cigarette) within 6 months prior to screening. Or a participant who is unwilling to abstain from tobacco or nicotine containing product use during the study.
  • Evidence, as reported by an alcohol breath testing, for current alcohol abuse or reports a regular average alcohol consumption exceeding 18 g (women) or 35 g (men) of pure alcohol per day, that is (i.e.) 1 drink/day for women or 2 drinks/day for men [1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05737069). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

Back to search