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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01343290

Enrollment

Registered

2011-04-28

Start date

2011-04-30

Completion date

2011-06-30

Last updated

2012-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Canagliflozin (JNJ-28431754), Pharmacokinetic, Oral Bioavailability, Food effect

Brief summary

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

Detailed description

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.

Interventions

DRUGCanagliflozin

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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)

Design outcomes

Primary

Measure	Time frame
Concentration of canagliflozin in plasma samples	For up to 8 days

Secondary

Measure	Time frame
Adverse events reported	Up to approximately 34 days
Vital signs measurements	Up to approximately 34 days
Results from clinical chemistries performed	Up to approximately 34 days
Results from 12-lead ECGs performed	Up to approximately 34 days

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026