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To Evaluate the Food Effect and the Absorption Profile of Ibuprofen Modified-Release Tablets 800 mg

CompletedPhase 1NCT05329454
View the official record on ClinicalTrials.gov

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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

An open-label, randomized, 3-way crossover study to evaluate the pharmacokinetics of investigational product "Ibuprofen Modified-Release Tablets 800 mg" in comparison to the reference standard "Ibuprofen Regular-Release Tablets 600 mg/800 mg" in normal healthy volunteers Primary objective: To evaluate the food effect of IBUMR and its bioavailability of single and multiple doses compared with reference drugs in normal healthy volunteers. Secondary objectives: 1. To determine and compare the single and multiple dose PK profiles of IBUMR and reference drugs. 2. To identify the effect duration for IBUMR after dose administration by detecting ibuprofen concentrations in plasma. 3. To evaluate the safety profile of single and multiple doses of IBUMR.

Study details

Official title
An Open-label, Randomized, 3-way Crossover Study to Evaluate the Pharmacokinetics of Investigational Product Ibuprofen Modified-Release Tablets 800 mg Compared to Ibuprofen Tablets 800 mg in Healthy Volunteers
Conditions
Interventions
  • Drug: Ibuprofen Tablets
Sponsor
Overseas Pharmaceuticals, Ltd.
Start date
2020-12-24
Primary completion
2021-02-06
Sex
All
Age range
from 18 Years
Healthy volunteers
true
Results posted
No results posted in this snapshot
Countries
China
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Subjects whose body mass index (BMI) at screening is within a range of ≥18.5 kg/m2 and \<25.0 kg/m2. BMI = Body Weight (kg) / \[Height (m)\]2 And body weight is not less than 50 kg and 45 kg for males and females, respectively. * Subject's medical history shows no contraindication to the test medications (hypersensitivity to ibuprofen or any component of test and reference products) and non-steroidal anti-inflammatory drugs (NSAIDs). * Subjects who are judged to be in good health by the investigator based upon the results of physical examination (PE), vital signs, and routine laboratory tests. * The female subject shows negative pregnancy test results within 30 days prior to the first dose of the study. * The subject did not take any of the following medications in the specified durations: * Any systemically absorbed medication within 14 days (excluding vitamins, food supplements and hormone contraceptives not ibuprofen drug interactions) prior to the first dose of the study * Any enzyme inducer/inhibitor and/or known hepatic or renal clearance-altering agents (e.g., erythromycin, cimetidine, barbiturates, phenothiazine, clarithromycin, troleandomycin, ketoconazole, miconazolem fluconazole, itraconazole) within 30 days prior to the first dose of the study. * Subjects are willing to comply with protocol-stated requirements, instructions and restrictions, followed by understanding and signing the written informed consent form by the subject or legal representative if he/she is under the statutory age of consent as per the local authority. Exclusion Criteria: * Subjects with any properly diagnosed disease within 30 days prior to the first dose of the study. * Subjects with a clinically significant hematological, endocrine, cardiovascular, hepatic, renal, gastrointestinal, and/or pulmonary disorder; subjects with any predisposing condition that might interfere with the absorption, distribution, metabolism and excretion of drugs; subjects who has had any previous gastrointestinal surgery or coronary artery bypass graft. * Subjects who require treatment with any medications, either prescription or non-prescription (excluding vitamins and food supplements), within 30 days prior to the first dose of the study * Subjects have participated in investigational drug trials and took any investigational drug within 60 days prior to the first does of the study. * Subjects had blood donation more than 250 and 500 mL within 60 and 90 days, respectively…

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT05329454