Evaluation of Green Propolis as a oral Anti-inflammatory Drug

Phase 2

Recruiting

• Conditions: Healthy volunteers; SP5.001.047.138

• Registration Number: RBR-9zmfs9
• Lead Sponsor: Faculdade de Medicina de Ribeirão Preto - FMRP

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-08-21
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

Healthy volunteers of both genders, non-smokers, aged 18 to 60 years and weighing within 15% of the normal weight for men and women taking into account their height and physical structure will be included. Participation of female volunteers is conditioned to not be pregnant or breastfeeding.

Exclusion Criteria

Volunteers with a history of smoking, alcoholism or drugs abuse, diagnosed as having any cardiac, renal, gastrointestinal, hepatic and pulmonary disease, neurological, psychiatric, hematological or metabolic disorders will be excluded. Also individuals with any known hypersensitivity to drugs who are receiving medications one week before the study or during its implementation and not willing to participate in all stages of this study will not be accept.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The endpoint expected on safety protocols is a non-significant change on activity of citochrome P450 enzymes or P-glycoprotein. The statistical approach for the analysis of potential interaction between propolis extract-fexofenadine will be based on geometrical mean ratio of the observed pharmacokinetic measures for fexofenadine with and without the propolis extract (EPP-AF). The conclusion of non-interaction will be done if the CI90% for log AUC ratio or log Cmax ratio of fexofenadine obtained with or without EPP-AF lies on 0.80 to 1.25 interval to AUC and 0.70 to 1.43 to Cmax. <br>For citochrome P450 interaction the same strategy will be done, using CI90% for AUC, metabolic ratio or clearance according the probe (drug) used. <br>For efficacy protocol the endpoint is set as a reduction of at least 50% from baseline urinary Prostaglandin E2 excretion with the use of higher doses of propolis extract (EPP-AF)

Secondary Outcome Measures

Name	Time	Method
ot applicable.