Phase I Clinical Study, Open-label, Randomized, Parallel to Evaluate the Safety of the 200 mg Dexibuprofen Following Single and Multiple Dose Oral Administration in Healthy Participants of Both Sexes Under Fasting and Fed Conditions.

DEXAPS0716OR-LD

Phase I Study to Evaluate the Safety of Dexibuprofen 200mg (Apsen Pharmaceuticals A / S.) After a Single and Multiple Dose Oral Administration in Healthy Participants of Both Sexes Under Fasting and Fed Conditions.

2018-04-01

2018-07-01

2018-07-01

Completed

Early phase I

52

Inclusion Criteria: * Participant able to understand and sign the informed consent of the study; * Healthy research participant, of both sexes, aged between 18 and 50 years, with BMI between 18.50 and 29.99 kg / m2; * Participant considered healthy by evaluating the medical history, vital signs and general clinical examination; * The results of clinical laboratory tests (biochemistry, hematology, serology, urinalysis and ECG certified by cardiologists) within the normal range established by the laboratory or changes that are considered not clinically significant by study physician. Exclusion Criteria: * History of any major surgery in the last three months; * History present or previous history of any cardiac event, gastrointestinal, respiratory, hepatic, renal, endocrine, neurological, metabolic, psychiatric, hematologic, considered by the investigator as clinically significant and can endanger the participant's health; * History of chronic alcohol abuse, drugs, drugs and / or smoking in the last 6 months; * Known hypersensitivity to dexibuprofen, ibuprofen or its related (other nonsteroidal anti-inflammatory drugs) as well as components present in the formulation; * History of use of drugs that potentially interfere with the kinetics / dynamics dexibuprofen or any other medication considered clinically significant by the investigator with time less than 7 times of drug half-life preceding the period of inclusion; * Regular consumption of grapefruit and / or their derivatives; * Pregnant women and nursing mothers; * Donation or loss of 450 ml or more of blood within 3 months before the study and / or hospitalization for any reason, up to 4 weeks before the beginning of it. * Participation in any clinical trial in the last 12 months preceding the start of the study.

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2023-02-09