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

Phase 2

Completed

• Conditions: Food-drug Interaction
• Interventions: Drug: Montelukast 10mg; Drug: Celecoxib 100mg

• Registration Number: NCT04374981
• Lead Sponsor: Damanhour University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-07-01
• Primary Completion: 2019-11-01
• Study Completion: 2019-12-01
• Study First Submitted: 2020-04-24
• Status Verified: 2020-05
• Study First Submitted QC: 2020-05-02
• Last Update Submitted: 2020-05-02
• Study First Posted: 2020-05-05
• Last Update Posted: 2020-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 24

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Montelukast	Montelukast 10mg	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.
Celecoxib	Celecoxib 100mg	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.

Primary Outcome Measures

Name	Time	Method
The terminal elimination half-life (t1/2)	12 weeks
The area under the concentration-time curve from zero to infinity (AUC0-∞)	12 weeks
Time to reach plasma peak concentration [Tmax]	12 weeks
Maximum Plasma Concentration [Cmax]	12 weeks
Time to reach maximum plasma concentration [Tmax]	12 weeks

Secondary Outcome Measures

Name	Time	Method
Clearance (CLT/F)	12 weeks

Trial Locations

Locations (1)

Faculty of Pharmacy-Damanhour University.; 🇪🇬 Damanhūr, Egypt