Phase I Study to Evaluate the Safety of Dexibuprofen 300mg Under Fasting and Fed Conditions

NCT ID: NCT02956512

Last Updated: 2020-11-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-18
• Study Completion Date: 2019-09-06

Brief Summary

Phase I Study to Evaluate the Safety of Dexibuprofen 300mg (Apsen Pharmaceuticals A / S.) After a Single and Multiple Dose Oral Administration in Healthy Participants of Both Sexes Under Fasting and Fed Conditions.

Detailed Description

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.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dexibuprofen 300mg - Fed

Fed condition

Group Type: EXPERIMENTAL

Dexibuprofen

Intervention Type: DRUG

Dexibuprofen 300mg

Dexibuprofen 300mg - Fasting

Fasting condition

Group Type: EXPERIMENTAL

Dexibuprofen

Intervention Type: DRUG

Dexibuprofen 300mg

Interventions

Dexibuprofen

Dexibuprofen 300mg

Intervention Type: DRUG

Eligibility Criteria

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 30.00 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Apsen Farmaceutica S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dra. Regina Mayumi Doi, MD

Role: PRINCIPAL_INVESTIGATOR

Azidus

Locations

Azidus laboratories Ltd.

Valinhos, São Paulo, Brazil

Countries

Brazil

Other Identifiers

DEXAPS0716OR-HD

Identifier Type: -

Identifier Source: org_study_id