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

Damanhour University

Status and phase: Completed; Phase 2

Conditions: Food-drug Interaction

Treatments: Drug: Montelukast 10mg; Drug: Celecoxib 100mg

Study type: Interventional

Funder types: Other

Identifiers

NCT04374981

CMP

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: Male

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Celecoxib

Experimental group

Description:

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.

Treatment:

Drug: Celecoxib 100mg

Montelukast

Experimental group

Description:

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.

Treatment:

Drug: Montelukast 10mg