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NCT04374981 Clinical Trial

Effect of Pineapple Juice on the Pharmacokinetics of Celecoxib and Montelukast in Humans

Food-drug Interaction Clinical Trial

Official title:
Effect of Pineapple Juice on the Pharmacokinetics of Celecoxib and Montelukast in Humans

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04374981
Other study ID # CMP
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date July 1, 2019
Est. completion date December 1, 2019

Study information
Verified date May 2020
Source Damanhour University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 24
Est. completion date December 1, 2019
Est. primary completion date November 1, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria:

- Healthy subjects (body mass index between 21 to 25 kg/m2).

Exclusion Criteria:

- Smokers.

- Drug abuse.

- Abnormal level of kidney or liver functions.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Celecoxib 100mg
Tablets
• Montelukast 10mg
Tablets

Locations
Country Name City State
Egypt Faculty of Pharmacy-Damanhour University. Damanhur

Sponsors (1)
Lead Sponsor Collaborator
Damanhour University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Maximum Plasma Concentration [Cmax] 12 weeks
Primary Time to reach plasma peak concentration [Tmax] 12 weeks
Primary Time to reach maximum plasma concentration [Tmax] 12 weeks
Primary The area under the concentration-time curve from zero to infinity (AUC0-8) 12 weeks
Primary The terminal elimination half-life (t1/2) 12 weeks
Secondary Clearance (CLT/F) 12 weeks
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