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

NCT ID: NCT04374981

Last Updated: 2020-05-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-01

Study Completion Date

2019-12-01

Brief Summary

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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.

Detailed Description

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Conditions

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Food-drug Interaction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Celecoxib

Twelve 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.

Group Type EXPERIMENTAL

Celecoxib 100mg

Intervention Type DRUG

Tablets

Montelukast

Twelve 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.

Group Type EXPERIMENTAL

Montelukast 10mg

Intervention Type DRUG

Tablets

Interventions

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Celecoxib 100mg

Tablets

Intervention Type DRUG

Montelukast 10mg

Tablets

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Damanhour University

OTHER

Sponsor Role lead

Responsible Party

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Sally Helmy, PhD, CPHQ

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sally Helmy, PhD

Role: PRINCIPAL_INVESTIGATOR

Damanhour University

Locations

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Faculty of Pharmacy-Damanhour University.

Damanhūr, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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CMP

Identifier Type: -

Identifier Source: org_study_id

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