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OpenTrials
Completed

NCT Number: NCT04374981

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.

Completed

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Key information

Conditions

Food-drug Interaction

Age range

18 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Faculty of Pharmacy-Damanhour University.

Damanhūr, 22511, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Celecoxib 100mg

Drug

Tablets

Montelukast 10mg

Drug

Tablets

Primary outcomes

  1. Maximum Plasma Concentration [Cmax]

    Time frame: 12 weeks

  2. Time to reach plasma peak concentration [Tmax]

    Time frame: 12 weeks

  3. Time to reach maximum plasma concentration [Tmax]

    Time frame: 12 weeks

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

    Time frame: 12 weeks

  5. The terminal elimination half-life (t1/2)

    Time frame: 12 weeks

Secondary outcomes

  1. Clearance (CLT/F)

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Damanhour University

Other

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
May 5, 2020
Registry last updated
May 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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