Osteoarthritis
Conditions
Interventions
First Dose:single-dose
Second Dose:Single-Dose once, 6 days after 70 mg BID x 7 days
Third Dose:Single-Dose once, 6 days after 140mg BID x 7 days
Fourth Dose:Single-Dose
Sponsors
Beijing Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Male or female, each sex ratio does no less 1/3; 2. Were between the ages of 18 and 45 years, inclusive. General condition is will; 3. Were between the Body Mass Index(BMI) of 19-28, inclusive; BMI=Weight(kg)/Height2(m2); Weight=50kg(female)and 60kg(male); 4. Nearly half of the year, no child care program and agree to take effective measures to contraception during the study period, blood pregnancy test of women in childbearing age was negative; 5. Vital signs (measurement seated after resting 5 minutes) in the following range (1) Temperature (auxillary temperature): 35.0-37.0 degree C; (2) Systolic Pressure: 90-139mmHg; (3) Diastolic Pressure: 60-89mmHg; (4) sphygmus: 55-99bpm. 6. Subjects to fully understand the purpose, properties, method and reactions may occur of test drug trials. Were capable of giving informed consents voluntarily, and agreed to comply with the requirements of clinical protocols.
Exclusion criteria
Exclusion criteria: 1. Primary disease in important organs; 2. Mental or physical disability; 3. Familial hereditary diseases; 4. Clinically significant history of Electrocardiograph(ECG) abnormality, or Electrocardiograph(ECG) abnormality in the Screening or Baseline; 5. Clinically significant abnormities in laboratory examination: (1) Clinically significant abnormities in Liver Function Tests, for example aspartate aminotransferase(AST), alanine aminotransferase (ALT), alkaline phosphatase(ALP) or bilirubin. (2) Creatinine and Urea Nitrogen exceeded the upper limit of normal, or significant abnormities in urinary composition. (3) Clinically significant abnormities of routine blood test, for example anemia, Leukocyte reduced, Platelet significantly reduced,etc.(Combined with adverse events in the laboratory to determine the value of abnormal). (4) Abnormality of immunology, including HIV(human immunodeficiency virus) antibody positive, Hepatitis B surface antigen (HBsAg) positive, HCV(hepatitis C virus) antibody positive or Syphilis antibody positive. 6. Drug abusers; 7. Who was addicted to alcohol and tobacco (drinking 14 units of alcohol per week: 1 unit = beer 285 ml, or liquor 25 ml, or wine 1 cup. numbers of daily smoking >=5) and/or not smoking and drinking in the test period; 8. Took any drug long excretory phase that may affect the study, or in the past 3 months participated in any drug clinical trials; 9. Entering the group 4 weeks ago used any prescription drugs ,or used any over the counter (OTC) drugs within 2 weeks (vitamins, herbal tonics, etc.), or before entering the group within 2 weeks took excessively food that effected drug metabolizing enzymes, such as grapefruit or grapefruit drink. Can the use of acetaminophen, but must record report in case report form (CRF); 10. A history of gastrointestinal bleeding or peptic ulcers, drugs allergy for aspirin or hypersensitivity to aspirin or other NSAIDs (Non-Steroidal Antiinflammatory Drugs), or a history of asthma or other allergic-type reactions after taking aspirin or other NSAIDs (Non-Steroidal Antiinflammatory Drugs); A history of intolerance or hypersensitivity to ibuprofenamine hydrochloride or any excipients or to the diluent ethanol; 11. Donation or blood collection, or acute loss of blood during the 3 months prior to screening( more than 400ml); 12. Had skin diseaseswound or other symptom, investigators consider that maybe unsafe for subjects or effect of evaluation for application sites; 13. There was a clinical significance history of allergy for drugs or food, or atopic allergic diseases (asthma, urticaria, eczema dermatitis) or a known drug allergy for test drugs or similar drugs; 14. Lactating women, pregnant women or unable to take effective contraceptive measures; 15. Researchers believed that participants not suitable to take the test for other factors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety (AE, physical examination, monitoring of vital signs, Laboratory examination, ECG, Skin irritation evaluation etc.); | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics; | — |
Countries
China
Contacts
Public ContactAixin Shi
Beijing Hospital
Outcome results
None listed