A comparison of two different formulations of Ibuprofen in healthy volunteers
- Conditions
- Healthy volunteer trialNot Applicable
- Registration Number
- ISRCTN91129283
- Lead Sponsor
- Reckitt Benckiser (United Kingdom)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 28
1. Participant has provided written informed consent
2. Comprehension of the nature and purpose of the study and willingness to comply with the requirements of the entire study
3. Healthy, adult, human volunteers of any race within the age range of 18 to 55 years (both inclusive)
4. Body Mass Index (BMI) = 18.5 kg/m2 to = 30 kg/m2
5. Haemoglobin: =12.0 gm% for male and =11.5 gm% for female
6. Electrocardiogram (ECG) (normal standard ECG in 12 leads after 10 minutes of rest in the supine position should meet the following parameters: 120 ms 7. Female participants of childbearing potential willing to use a highly effective method of contraception throughout the study and for one menstrual cycle after last drug administration
8. Negative serum ß-Human Chorionic Gonadotrophin (HCG) at the time of screening (for females only)
9. Female participants who are post-menopausal or permanently sterilised (e.g. tubal occlusion, hysterectomy, bilateral salpingectomy). These subjects are not required to use contraception
10. Male participant who is willing to use contraception with their partner throughout the study (unless anatomically sterile) and agree to inform the Investigator if their partner becomes pregnant during this time. A man is considered fertile after puberty unless permanently sterile by bilateral orchidectomy
11. Absence of disease markers of human immunodeficiency viruses (HIV I & II), Hepatitis B surface Antibody (HBsAg), Hepatitis C surface Antibody (HCVAb) and P24 antigen test
12. The investigator confirmed that within the last 12 months there is nothing in their medical history that would preclude their enrolment into the study
1. Female participant who is pregnant as confirmed by a positive pregnancy test (serum at screening and urine test at day -1 of each treatment period) or is lactating
2. History of undiagnosed vaginal bleeding (for females only)
3. In the opinion of the investigator, the participant has a clinically significant history of asthma or a documented intolerance to NSAIDs resulting in exacerbation of symptoms
4. In the opinion of the investigator, any participant with a clinically relevant history of peptic or duodenal ulcers, gastrointestinal bleeding or perforation, frequent dyspepsia, migraine headaches, heart failure, renal or hepatic failure, uncontrolled hypertension, nasal polyps, or chronic rhinitis
5. History of chronic diarrhea or vomiting
6. Currently have or history of systemic lupus erythematosus and mixed connective tissue disease
7. History / evidence of allergy or hypersensitivity to Ibuprofen, aspirin, other NSAID, Paracetamol or to any components of the formulations or other allergy that, in the opinion of the investigator contraindicates their participation
8. Participant has a current and previous clinically significant medical history as deemed by the Investigator including but not limited to cardiovascular, respiratory, gastrointestinal, neurological, metabolic, or psychiatric disorders
9. Any major illness in last 12 months or any significant ongoing chronic medical illness, significant history of disease or metabolism disorder.
10. Participant has any condition that may currently interfere with the absorption, distribution, metabolism or excretion of drugs
11. Participant has a history of drug or alcohol abuse, in the opinion of the Investigator, in the two years prior to screening or a positive test for drugs of abuse and alcohol at screening
12. Participant has received an investigational product, or participated in another trial involving a marketed or investigational drug in the 90 days prior to first drug administration
13. Participant has previously been enrolled (randomised) into the current study
14. Participant who is an employee at the site or a partner or first-degree relative of the Investigator
15. Participant has used prescription drugs or vitamins, herbal and dietary supplements, including St. John’s Wort, consumption of large quantities of methylxanthine-containing beverages (>5 cups of coffee/day or equivalent), grapefruit, cranberry or juices of these fruits at any time in the 14 days prior to drug administration until the collection of the last PK sample in treatment period 2 or OTC drugs at any time in the 7 days before first drug administration
16. Participant is a current smoker or ex-smoker who has smoked or used nicotine replacement products during the 45 days before screening
17. Participant has a known human immunodeficiency virus (HIV) positive status, or a positive viral serology screen
18. Participant has donated 450 mL or more of blood or blood products or had significant loss of blood in the 90 days prior to first drug administration
19. Haemoglobin level is below 11 gm/dL or for whom it drops >2gm/dL (compared to screening) during the study
20. Participant fails to satisfy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method