Phase I Study to Evaluate the Safety of Dexibuprofen 200mg Under Fasting and Fed Conditions

Apsen Farmaceutica S.A.52 enrolled

Overview

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.

A single oral dose of test medicine will be administered to participants in a practical period with the aid of 200 mL of water at room temperature. During administration, participants should stay in seated position. Participants will be confined at least 12 hours prior to administration and will remain for about 24 hours after the same, totaling about 36 hours of confinement. After 36 hours of confinement the participantes will proceed to the multi-dose use phase for seven days in fed conditions. To assess safety, an evaluation of the vital signs, laboratory tests and health status of the participants will be carried out throughout the study.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Healthy Volunteers

Interventions

DexibuprofenDRUG

Dexibuprofen 200 mg

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Azidus laboratories Ltd.

Valinhos, São Paulo, Brazil

Outcomes

Primary Outcomes

To assess the safety of the drug through the incidence and classification of adverse events following single and multiple dose administration.

Adverse events both recorded in the single-dose and multiple-dose

Time frame: 40 days

Secondary Outcomes

To evaluate the pharmacokinetics of the drug dexibuprofen at 200 mg concentration after single dose oral administration under fasting and fed conditions.

Evaluation of pharmacokinetic parameters: Tmax, Cmax, AUC, DV, Kel, CL and T1/2.

Time frame: 36 hours

Data from ClinicalTrials.gov

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