ACTRN12615000078550CompletedPhase 1
A multiple dose, randomized, blinded, bioequivalence study of ibuprofen sustained release tablets in a 2 way crossover comparison against the innovator ibuprofen tablet conducted under fasting conditions and at steady state in healthy male and female volunteers
Zenith Technology Corporation Limited0 sites24 target enrollmentStarted: January 29, 2015Last updated:
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 24
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomised controlled trial
- Primary Purpose
- Treatment
- Masking
- Blinded (masking used)
Eligibility Criteria
- Ages
- 18 Years to 55 Years (—)
- Sex
- All
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.
Investigators
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