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

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ClinicalTrials.gov Identifier: NCT02956512
Recruitment Status : Not yet recruiting
First Posted : November 7, 2016
Last Update Posted : December 14, 2017
Sponsor:
Information provided by (Responsible Party):
Apsen Farmaceutica S.A.

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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: Dexibuprofen Phase 1

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Estimated Study Start Date : April 2018
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2018

Arm Intervention/treatment
Experimental: Dexibuprofen 300mg - Fed
Fed condition
Drug: Dexibuprofen
Dexibuprofen 300mg

Experimental: Dexibuprofen 300mg - Fasting
Fasting condition
Drug: Dexibuprofen
Dexibuprofen 300mg




Primary Outcome Measures :
  1. To assess the safety of the drug through the incidence and classification of adverse events following single and multiple dose administration. [ Time Frame: 40 days ]
    Adverse events both recorded in the single-dose and multiple-dose


Secondary Outcome Measures :
  1. To evaluate the pharmacokinetics of the drug dexibuprofen at 300 mg concentration after [ Time Frame: 36 hours ]
    Evaluation of pharmacokinetic parameters: Tmax, Cmax, AUC, DV, Kel, CL and T1/2.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02956512


Contacts
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Contact: Fernanda Martinez, B.Sc.(Pharm) + 55 11 5644-8200 ext 8404 pesquisa.clinica@apsen.com.br

Locations
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Brazil
Azidus laboratories Ltd. Not yet recruiting
Valinhos, São Paulo, Brazil, 03186010
Sponsors and Collaborators
Apsen Farmaceutica S.A.
Investigators
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Principal Investigator: Dra. Regina Mayumi Doi, MD Azidus

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Responsible Party: Apsen Farmaceutica S.A.
ClinicalTrials.gov Identifier: NCT02956512     History of Changes
Other Study ID Numbers: DEXAPS0716OR-HD
First Posted: November 7, 2016    Key Record Dates
Last Update Posted: December 14, 2017
Last Verified: December 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ibuprofen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action