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

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 Overview

• Status: Completed
• Conditions: Food-drug Interaction
• Intervention / Treatment: Drug: Celecoxib 100mg; Drug: Montelukast 10mg

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 2

Contacts and Locations

Study Locations

• Egypt
  • Damanhūr, Egypt, 22511
    • Faculty of Pharmacy-Damanhour University.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Drug: Celecoxib 100mg; Tablets
EXPERIMENTAL: 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.	Drug: Montelukast 10mg; Tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Clearance (CLT/F)	12 weeks

Collaborators and Investigators

• Sponsor: Damanhour University
• Investigators: Principal Investigator: Sally Helmy, PhD, Damanhour University

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2019
• Primary Completion (ACTUAL): November 1, 2019
• Study Completion (ACTUAL): December 1, 2019

Study Registration Dates

• First Submitted: April 24, 2020
• First Submitted That Met QC Criteria: May 2, 2020
• First Posted (ACTUAL): May 5, 2020

Study Record Updates

• Last Update Posted (ACTUAL): May 5, 2020
• Last Update Submitted That Met QC Criteria: May 2, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Anti-Asthmatic Agents; Respiratory System Agents; Leukotriene Antagonists; Hormone Antagonists; Cytochrome P-450 CYP1A2 Inducers; Cytochrome P-450 Enzyme Inducers; Cyclooxygenase 2 Inhibitors; Montelukast; Celecoxib
• Other Study ID Numbers: CMP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No