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About
The main objective of the study is to evaluate the bioequivalence of a new formulation of ibuprofen 200 mg/5 mL oral suspension vs. the marketed reference product MOMENT 200 mg coated tablet, when administered under fasting conditions as single oral dose to healthy male and female volunteers, in two consecutive study periods.
Enrollment
Sex
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Volunteers
Inclusion criteria
To be enrolled in this study, subjects must fulfil all these criteria:
Informed consent: signed written informed consent before inclusion in the study
Sex and Age: males/females, 18-55 years old inclusive
Body mass index (BMI): 18.5-30 kg/m2 inclusive
Vital signs: systolic blood pressure (SBP) 100-139 mmHg, diastolic blood pressure (DBP) 50-89 mmHg, heart rate (HR) 50-90 bpm, measured after 5 min at rest in the sitting position
Full comprehension: ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to co-operate with the investigator and to comply with the requirements of the entire study
Contraception and fertility (females only): females of child-bearing potential must be using at least one of the following reliable methods of contraception:
Exclusion criteria
60 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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