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Completed

NCT Number: NCT01343290

The Effect of Food on the Administration of Canagliflozin in Healthy Adult Volunteers

The purpose of this study is to assess the effect of food on the absorption of canagliflozin in the body when canagliflozin is taken with and without food by healthy volunteers

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

About this study

This is a single-center, single-dose, open-label (volunteers will know the identity of assigned treatment), randomized (one of 2 study drug sequences assigned by chance) study to evaluate the oral bioavailability (the degree to which the drug is absorbed in the body when taken orally by mouth) of canagliflozin when taken with and without food in healthy volunteers. Healthy Volunteers will take 1 canagliflozin tablet orally for 1 day in 2 treatment periods (canagliflozin will be taken with food in 1 treatment period and canagliflozin will be taken without food in 1 treatment period); the 2 treatment periods will be separated by a 10- to 14-day washout period.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy volunteers with a body mass index between 18 and 30 kg/m2 (inclusive) and body weight not less than 50 kg

Exclusion criteria

  • of or current medical illness deemed clinically significant by the Investigator (study physician)

Treatment and study plan

Canagliflozin

Drug

Type = 1, unit = mg, number = 300, form = tablet, route = oral use. Single tablet taken with or without a meal during 2 treatment periods

Primary outcomes

  1. Concentration of canagliflozin in plasma samples

    Time frame: For up to 8 days

Secondary outcomes

  1. Adverse events reported

    Time frame: Up to approximately 34 days

  2. Vital signs measurements

    Time frame: Up to approximately 34 days

  3. Results from clinical chemistries performed

    Time frame: Up to approximately 34 days

  4. Results from 12-lead ECGs performed

    Time frame: Up to approximately 34 days

Sponsors and collaborators

Lead sponsor

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Industry

Registry information

Official study title

A Single-Dose, Open-Label, Randomized, 2-Period, 2-Sequence, Crossover Study to Determine the Effect of Food Coadministration on the Pharmacokinetics of 300 mg Canagliflozin in Healthy Subjects

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Apr 28, 2011
Registry last updated
Oct 2, 2012

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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