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Completed

NCT Number: NCT01459094

Effect of Food on a Fixed Dose Combination Tablet of Canagliflozin and Metformin Immediate Release in Healthy Volunteers

The purpose of this study is to see if the absorption and distribution of a fixed-dose Combination (FDC) tablet of canagliflozin and metformin IR is affected when taken with food by healthy volunteers.

Completed

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

About this study

This is an open-label (identity of study drug will be known to volunteers and study staff), single-center study to evaluate the oral bioavailability (ie, absorption and distribution within the body) and pharmacokinetics (blood levels) of a single dose of 1 fixed-dose combination (FDC) tablet of canagliflozin and metformin IR (abbreviated as 1 CANA/MET IR FDC tablet) when taken by healthy volunteers without food (in a fasting state) or with food (in a fed state). Healthy volunteers participating in the study will be randomly (by chance) assigned to receive Treatment A (1 CANA/MET IR FDC tablet taken by healthy volunteers in a fasting state) followed approximately 14 days later by Treatment B (1 CANA/MET IR FDC tablet taken by healthy volunteers in a fed state) or Treatment B followed approximately 14 days later by Treatment A.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

- Body mass index (BMI) between 18 and 30 kg/m² inclusive and a body weight of not less than 50 kg. Exclusion Criteria: - History of or current medical illness, abnormal values for hematology or clinical chemistry laboratory tests, or abnormal physical examination, vital signs or 12-lead electrocardiogram (ECG) deemed to be clinically significant by the Investigator

Treatment and study plan

A (CANA/MET IR FDC tablet - fasting state) / B (CANA/MET IR FDC tablet - fed state)

Drug

Treatment A: Type = 1, unit = mg, number = 150/1000, form = tablet, route = oral use. One CANA/MET IR FDC tablet taken orally (by mouth) in a fasting state on Day 1 of Treatment Period 1 followed 10-14 days later by Treatment B: Type = 1, unit = mg, number = 150/1000, form = tablet, route = oral use. One CANA/MET IR FDC tablet taken orally in a fed state on Day 1 of Treatment Period 2.

B (CANA/MET IR FDC tablet - fed state) / A (CANA/MET IR FDC tablet - fasting state)

Drug

Treatment B: Type = 1, unit = mg, number = 150/1000, form = tablet, route = oral use. One CANA/MET IR FDC tablet taken orally in a fed state on Day 1 of Treatment Period 1 followed 10-14 days later by Treatment B: Type = 1, unit = mg, number = 150/1000, form = tablet, route = oral use. One CANA/MET IR FDC tablet taken orally in a fasting state on Day 1 of Treatment Period 2.

Primary outcomes

  1. Canagliflozin plasma concentrations

    Time frame: Up to 72 hours

  2. Metformin plasma concentrations

    Time frame: Up to 24 hours

Secondary outcomes

  1. Adverse events

    Time frame: Up to approximately 22 days

    The number and type of adverse events will be reported from Day 1 of treatment period 1 through 7-10 days after treatment period 2 including the 10-14 day washout period between treatment periods (total time is approximately 22 days).

  2. Clinical Laboratory Tests

    Time frame: Up to approximately 22 days

    Clinically relevant changes from baseline occurring in laboratory safety parameters

  3. Vital Signs

    Time frame: Up to approximately 22 days

    Changes from baseline in blood pressure and pulse

Sponsors and collaborators

Lead sponsor

Janssen Research & Development, LLC

Industry

Registry information

Official study title

Single-Dose, Open-Label, Randomized, 2-Period Crossover Study to Assess the Effect of Food Coadministration on the Pharmacokinetics of a Fixed Dose Combination Tablet of Canagliflozin and Metformin Immediate Release in Healthy Subjects

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Oct 25, 2011
Registry last updated
Feb 20, 2013

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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