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

NCT02956512 | Completed Phase 1

• 1 other identifier: DEXAPS0716OR-HD
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• To evaluate the pharmacokinetics of the drug dexibuprofen at 300 mg concentration after

  36 hours

Study Arms (2)

Dexibuprofen 300mg - Fed

EXPERIMENTAL

Fed condition

Drug: Dexibuprofen

Dexibuprofen 300mg - Fasting

EXPERIMENTAL

Fasting condition

Drug: Dexibuprofen

Interventions

Dexibuprofen DRUG

Dexibuprofen 300mg

Dexibuprofen 300mg - Fasting; Dexibuprofen 300mg - Fed

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Apsen Farmaceutica S.A.: lead

Study Sites (1)

Azidus laboratories Ltd.

Valinhos, São Paulo, 03186010, Brazil

Location

MeSH Terms

Interventions

dexibuprofen

Study Officials

• Dra. Regina Mayumi Doi, MD

  Azidus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2016
• First Posted: November 7, 2016
• Study Start: March 18, 2019
• Primary Completion: July 12, 2019
• Study Completion: September 6, 2019
• Last Updated: November 18, 2020

Record last verified: 2020-11

Locations

BR (1)