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

Damanhour University24 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Food-drug Interaction

Interventions

Celecoxib 100mgDRUG

Tablets

Montelukast 10mgDRUG

Tablets

Eligibility

Sex: MALEMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Faculty of Pharmacy-Damanhour University.

Damanhūr, Egypt

Outcomes

Primary Outcomes

Maximum Plasma Concentration [Cmax]

Time frame: 12 weeks

Time to reach plasma peak concentration [Tmax]

Time frame: 12 weeks

Time to reach maximum plasma concentration [Tmax]

Time frame: 12 weeks

The area under the concentration-time curve from zero to infinity (AUC0-∞)

Time frame: 12 weeks

The terminal elimination half-life (t1/2)

Time frame: 12 weeks

Secondary Outcomes

Clearance (CLT/F)

Time frame: 12 weeks

Data from ClinicalTrials.gov

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