Effect of Pineapple Juice on the Pharmacokinetics of Celecoxib and Montelukast in Humans
1 other identifier
interventional
24
1 country
1
Brief Summary
Pineapple (Ananas comosus) is a tropical fruit that is rich in antioxidents, enzymes and vitamins. It is used worldwide due to their anti-inflammatory and analgesic properties. The effect of pineapple Juice on the Pharmacokinetics of celecoxib and montelukast in Humans was studied.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jul 2019
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedFirst Submitted
Initial submission to the registry
April 24, 2020
CompletedFirst Posted
Study publicly available on registry
May 5, 2020
CompletedMay 5, 2020
May 1, 2020
4 months
April 24, 2020
May 2, 2020
Conditions
Outcome Measures
Primary Outcomes (5)
Maximum Plasma Concentration [Cmax]
12 weeks
Time to reach plasma peak concentration [Tmax]
12 weeks
Time to reach maximum plasma concentration [Tmax]
12 weeks
The area under the concentration-time curve from zero to infinity (AUC0-∞)
12 weeks
The terminal elimination half-life (t1/2)
12 weeks
Secondary Outcomes (1)
Clearance (CLT/F)
12 weeks
Study Arms (2)
Celecoxib
EXPERIMENTALTwelve healthy male subjects participated in this arm under fasting condition. A randomized, open-label, 2-way crossover study design with 2-week washout period between treatments was used. Participants received a single oral dose of celecoxib tablets (100mg) after pre-treatment with 250ml of either pineapple juice or water (control) for four consecutive days before the beginning of the study.
Montelukast
EXPERIMENTALTwelve healthy male subjects participated in this arm under fasting condition. A randomized, open-label, 2-way crossover study design with 2-week washout period between treatments was used. Participants received a single oral dose of Montelukast tablets (10mg) after pre-treatment with 250ml of either pineapple juice or water (control) for four consecutive days before the beginning of the study.
Interventions
Eligibility Criteria
You may qualify if:
- Healthy subjects (body mass index between 21 to 25 kg/m2).
You may not qualify if:
- Smokers.
- Drug abuse.
- Abnormal level of kidney or liver functions.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculty of Pharmacy-Damanhour University.
Damanhūr, 22511, Egypt
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sally Helmy, PhD
Damanhour University
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate professor
Study Record Dates
First Submitted
April 24, 2020
First Posted
May 5, 2020
Study Start
July 1, 2019
Primary Completion
November 1, 2019
Study Completion
December 1, 2019
Last Updated
May 5, 2020
Record last verified: 2020-05
Data Sharing
- IPD Sharing
- Will share