Healthy volunteer trial Not Applicable
Conditions
Interventions
The study has a pivotal, open-label, randomised, balanced, two-treatment, two-period, two-sequence, single oral dose, and two-way crossover bioequivalence study design. The Test Formulation is: 2 x 20
Sponsors
Reckitt Benckiser (United Kingdom)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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<PR<220 ms, QRS<120 ms, QTcF=430 msec (males), QTcF=450 msec (females)) 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The following pharmacokinetic (PK) profile of the 2 x 200 mg Ibuprofen Formulation A (reference) and 2 x 200 mg Ibuprofen Formulation B (test) in healthy adults in the fasted state will be assessed on day 1 of treatment period 1 and day 1 of treatment period 2: 1. AUC0-t 2. Cmax 3. Tmax The endpoints will be measured using blood samples collected pre-dose (within an hour prior to dosing) and at 5, 10, 15, 20, 25, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 240, 360, 480 and 720 minutes for determination of ibuprofen plasma concentrations | — |
Secondary
| Measure | Time frame |
|---|---|
| The following PK endpoints will be assessed for test and reference products on day 1 of treatment period 1 and day 1 of treatment period 2: 1. T1/2 2. Kel 3. AUC (0-inf) 4. AUCEX (%) ([AUC0-inf - AUC0-t/AUC0-inf] * 100) The endpoints will be measured using blood samples collected pre-dose (within an hour prior to dosing) and at 5, 10, 15, 20, 25, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 240, 360, 480 and 720 minutes for determination of ibuprofen plasma concentrations. Safety and tolerability endpoints will be assessed for test and reference products: 1. Overall proportion of participants with adverse events (AEs), i.e. the occurrence of one or more AEs per participant. 2. The absolute value and change from baseline in each vital sign. 3. The absolute value and change from baseline in each haematology, biochemistry and urinary test. AEs will be measured using non-leading questions throughout the study on day -28 to day -1, day -1 (periods 1 and 2), day 1 (periods 1 and 2), and follow-up | — |
Countries
Northern Ireland, United Kingdom
Contacts
Public ContactStudy Mailbox
Outcome results
None listed