Phase I Study to Evaluate the Safety of Dexibuprofen 300mg Under Fasting and Fed Conditions
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02956512|
Recruitment Status : Unknown
Verified December 2017 by Apsen Farmaceutica S.A..
Recruitment status was: Not yet recruiting
First Posted : November 6, 2016
Last Update Posted : December 14, 2017
|Condition or disease||Intervention/treatment||Phase|
|Healthy Volunteers||Drug: Dexibuprofen||Phase 1|
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 (Clinical Trial)|
|Estimated Enrollment :||52 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
Experimental: Dexibuprofen 300mg - Fed
Experimental: Dexibuprofen 300mg - Fasting
- 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
- 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.
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
|Contact: Fernanda Martinez, B.Sc.(Pharm)||+ 55 11 5644-8200 ext firstname.lastname@example.org|
|Azidus laboratories Ltd.|
|Valinhos, São Paulo, Brazil, 03186010|
|Principal Investigator:||Dra. Regina Mayumi Doi, MD||Azidus|