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

This study consists of 3 treatment periods as below. For Treatment A and Treatment B, single- and multiple-dose stages are included.

Treatment A:

One tablet of IBUMR will be administered to the subjects under fasted condition, followed by a minimum of 72-hour washout interval. After the washout period, subjects will receive 1 × IBUMR every 12 hours for a total of 8 doses.

Treatment B:

One tablet of IBURed-800mg will be administered to the subjects under fasted condition, followed by a minimum of 72-hour washout interval. After the washout period, subjects will receive 1 × IBURed-600mg every 8 hours for a total of 12 doses.

Treatment C:

Single dose of IBUMR will be given to the subjects under fed condition (a standard high-fat, high calorie breakfast should be consumed within 30 minutes prior to dosing).

A minimum of 3-day washout interval will be introduced across the 3 treatment periods. Subjects will be required to be fasted for at least 10 hours prior to the administration of morning doses.

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 prior to the first dose of the study.
• Subjects had a history of drug abuse or alcohol abuse according to the Diagnostic and Statistical Manual of Mental Disorders 4th edition (DSM-IV) criteria.
• Subjects cannot stop smoking and caffeine-intakes for 48 hours prior to the first dose of the study and during the entire study period.
• Subjects who are pregnant or lactating.
• Subjects who have been tested positive for the following tests:
• Human immunodeficiency virus (HIV)
• Hepatitis B virus (HBV)
• Hepatitis C virus (HCV)
• Treponema pallidum (STS test)
• For enrollment of female subjects with child-bearing potential, the subject must be practicing sexual abstinence or be using and willing to continue to use a medically acceptable form of birth control for at least 30 days prior to screening (that period will extend to 3 months for oral contraceptive use) and for at least 30 days after the last dose of study drug. For a subject to be considered not to be of child-bearing potential, she must have been amenorrheic for at least 2 years, or must have had a hysterectomy, a bilateral tubal ligation, and/or a bilateral oophorectomy (as determined by the medical history). The male partner of a female study subject with childbearing potential must use a condom and ensure that his partner uses a suitable method of contraception as outlined above.
• Subjects with underlying medical, mental, psychological, or other inappropriate conditions that would impair treatment compliance, or in the opinion of the investigator would not permit to participate in the study.