Status:
TERMINATED
To Evaluate the Food Effect and the Absorption Profile of Ibuprofen Controlled-Release Tablets 600 mg in Comparison to the Reference Standard Ibuprofen Tablets in Normal Healthy Volunteers
Lead Sponsor:
Overseas Pharmaceuticals, Ltd.
Collaborating Sponsors:
Virginia Contract Research Organization Co., Ltd.
Conditions:
Pain Control
Eligibility:
All Genders
20+ years
Phase:
PHASE1
Brief Summary
To evaluate the food effect of Ibuprofen CR Tablets 600 mg (IBUCR), and its bioavailability comparison versus 3 doses of the reference arms including Advil® Ibuprofen Tablets 200 mg (IBUAdv) and Motri...
Detailed Description
This randomized, open label, four-way crossover phase I study is to evaluate the food effect of Ibuprofen CR Tablets 600 mg (IBUCR), and its bioavailability comparison versus 3 doses of the reference ...
Eligibility Criteria
Inclusion
- Subjects are 20 years of age or older.
- 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).
- Subjects who are judged to be in good health by the investigator based upon the results of physical examinations (PEs), chest X-ray (within 180 days prior to the first dose of the study) 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 medication within 14 days prior to the first dose of the study
- Any enzyme inducer or inhibitor within 30 days prior to the first dose of the study
- Subject understood and has signed the written informed consent form.
Exclusion
- 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, except appendectomy if performed \>90 days prior to the first dose of the study
- 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 who have received any known hepatic or renal clearance-altering agents (e.g., erythromycin, cimetidine, barbiturates, phenothiazine, clarithromycin, trolearndomycin, ketoconazole, miconazole, fluconazole, itraconazole) for a period of up to 30 days prior to the first dose of the study
- The subject had participated in investigational drug trials and took any investigational drug within 60 days prior to the first dose of the study.
- The subject had blood donation more than 250 and 500 mL within 60 and 90 days, respectively prior to the first dose of the study.
- The subject had a history of drug abuse or alcohol abuse.
- 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
- 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 who are inappropriate to participate in this study, as judged by the medical investigator or sub-investigator
- Subjects with any contraindication to the use of test medications
- Subjects who are carriers of hepatitis B virus, hepatitis C virus, or are syphilis (STS) positive, or human immunodeficiency virus (HIV) positive
Key Trial Info
Start Date :
December 11 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2020
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT03418805
Start Date
December 11 2017
End Date
December 31 2020
Last Update
April 1 2022
Active Locations (1)
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1
Tri-Service General Hospital
Taipei, Taiwan