A randomized, single dose, 2-way crossover, open study in healthy male volunteers to evaluate the pharmacokinetics and the safety of CDFR0111 and Vimovo tablet 500/20 mg
- Conditions
- Diseases of the musculo-skeletal system and connective tissue
- Registration Number
- KCT0001117
- Lead Sponsor
- CTC Bio
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 60
(1)Healthy male subjects between the ages of 20 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG or laboratory tests)
(2)Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight = 45 kg
(3) Subject who don't have Congenital or chronic diseases and have no abnormal medical examination results
(4) Subject is healthy (no clinically relevant findings in any of the investigations of the pre-examination) as judged by the investigator
(5) An informed consent document signed and dated by the subject
(1)Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (But excluding untreated, asymptomatic, seasonal allergies at time of dosing)
(2)Any condition possibly affecting drug absorption (e.g. gastrectomy)
(3)A positive urine drug screen
(4)History of regular alcohol consumption exceeding 21 drinks/week (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of Screening
(5)Participating in a bioequivalence study or other clinical study within 2 month preceding the first dose of investigational product
(6)Screening sitting blood pressure = 160 mm Hg (systolic) or = 90 mm Hg (diastolic), on measurement
(7)History of significant alcohol abuse or drug abuse within one year prior to the Screening
(8) Use of any drugs known to significantly induce (e.g., dexamethasone, phenytoin, carbamazepine, rifabutin, rifampicin, phenobarbital) or inhibit CYP3A4 (e.g., ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nelfinavir, ritonavir, telithromycin, and voriconazole) drug-metabolizing enzymes within 30 days (or 5 half-lives, whichever is longer) prior to dosing
(9) Use of cigarettes in excess of 20 per day
(10) Use of prescription or nonprescription drugs and dietary supplements within 10 days or 5 half-lives (whichever is longer) prior to the first dose of investigational product
(11)Blood donation of approximately 400 mL or more within 2 months prior to dosing, or plasma donation within 1 month prior to dosing
(12)Unwilling or unable to comply with the Lifestyle guidelines described in this protocol
(13)Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study
(14) Subject who has a clinically relevant allergy for study drugs
(15) Subject who has a history of aspirin or other NSAIDs (COX-2 inhibitors include) by the administration of asthma, rhinitis, nasal polyps, urticaria, or allergic reaction
(16) Patients with active peptic ulcer
(17) Gastrointestinal bleeding, cerebrovascular bleeding, patients with other bleeding disorders, patients with severe blood damage
(18) Patients with severe hepatic impairment
(19) Patients with severe heart failure
(20) Patients with severe renal impairment
(21) Patients with severe hypertension
(22) patients who treatment pain before and after caused by bycoronary artery bypass surgery (CABG)
(23) Patients who treated atazanavir or nelfinavir
(24)Subjects with hereditary diseases of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
(25) Subject who are inadequate for this study to partcipate judged by investigator
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method AUCt;Cmax
- Secondary Outcome Measures
Name Time Method