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

Healthy Volunteers Clinical Trial

Official title:

Phase I Clinical Study, Open-label, Randomized, Parallel to Evaluate the Safety of the 300 mg Dexibuprofen Following Single and Multiple Dose Oral Administration in Healthy Participants of Both Sexes Under Fasting and Fed Conditions.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02956512
• Other study ID #: DEXAPS0716OR-HD
• Status: Completed
• Phase: Phase 1
• Start date: March 18, 2019
• Est. completion date: September 6, 2019

Study information

• Verified date: November 2020
• Source: Apsen Farmaceutica S.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: September 6, 2019
• Est. primary completion date: July 12, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Dexibuprofen
Dexibuprofen 300mg

Locations

Country	Name	City	State
Brazil	Azidus laboratories Ltd.	Valinhos	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Apsen Farmaceutica S.A.

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	40 days
Secondary	To evaluate the pharmacokinetics of the drug dexibuprofen at 300 mg concentration after	Evaluation of pharmacokinetic parameters: Tmax, Cmax, AUC, DV, Kel, CL and T1/2.	36 hours