None listed
Conditions
Brief summary
The objective of this study is to evaluate the bioequivalence of the test (new) formulation of 800 mg ibuprofen sustained release tablet relative to that of the reference formulation (innovator brand of 800 mg ibuprofen sustained release tablet) following oral administration of a multiple dose of 800 mg in healthy male and female subjects under fasting conditions and at steady state.
Interventions
Multiple dose, crossover over study design whereby each participant receives the test formulation of ibuprofen (1 x 800 mg) on five occasions and the innovator formulation of ibuprofen (1 x 800 mg) on five occasions with each dose seperated by a 10 day washout period. The intervention for this trial is the test formulation of ibuprofen.
On study days 1-5 subjects will receive 5 daily doses of one formulation (either the test or innovator) and on study days 15-19 they will receive 5 daily doses
Multiple dose, crossover over study design whereby each participant receives the test formulation of ibuprofen (1 x 800 mg) on five occasions and the innovator formulation of ibuprofen (1 x 800 mg) on five occasions with each dose seperated by a 10 day washout period. The intervention for this trial is the test formulation of ibuprofen. On study days 1-5 subjects will receive 5 daily doses of one formulation (either the test or innovator) and on study days 15-19 they will receive 5 daily doses of the other formulation (either the innovator or test). Each dose (1 x 800 mg) will be taken orally with 240 ml of water at ambient temperature. Medication must be swallowed whole and a mouth check will be conducted to ensure the medication has been taken as directed. Participants are required not to eat for 10 hours before receiving each dose. On study days 1 to 4 and 15 to 18 subjects will report to Zenith Technology for dosing and the provision of one blood sample. They will then be given a light breakfast to consume following each dose at home. On study day 5 and 19 no water is allowed for 1 hour prior to dosing until 1 hour after dosing (except for the water consumed with the dose) and are required to fast for approximately 4 hours after receiving each dose. Bathroom visits will be supervised to ensure no unauthorised water or food intake and for personal safety. Participants will be confined at the Clinical Site for 10 hours prior to dosing to ensure compliance can be monitored and for 24 hours after dosing.
Sponsors
Zenith Technology Corporation Limited
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
Healthy males and non-pregnant females Aged between 18 and 55 Non-smoker BMI between 18 and 33 Normal, healthy individuals as determined by medical history, physical examination, ECG, blood pressure and laboratory tests Able to provide written informed consent
Exclusion criteria
Any history of recent recurrent attacks of bronchitis, asthma, migraine headaches Concomitant drug therapy of any kind excluding prescribed hormonal contraceptives Who have received an investigational compound or drug known to induce or inhibit liver enzymes within 60 days of the start of the study History or family history of depression or other mental illness, epilepsy or seizures Sensitivity to ibuprofen, any NSAID medicines, excipients of ibuprofen History of any conditions that might interfere with the absorption, distribution, metabolism or excretion of the drug Females who are breastfeeding or are planning to start a family within 60 days of dosing Who are planning on having any surgical or dental procedures within 4 weeks of the study completion Smoker (anyone who has smoked in the last 6 months) History of alcohol or drug abuse or dependency Participation in a drug study within 60 days of the start of the study or donated blood in the 60 days preceding the study. Volunteers for whom the Clinical Investigator believes, for any reason, that participation would not be an acceptable risk.
Outcome results
None listed