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OpenTrials
Completed

NCT Number: NCT01508182

A Study of Canagliflozin and Metformin Immediate Release (150 mg/500 mg) FDC Tablets in Healthy Volunteers

The purpose of this study is to evaluate the bioequivalence of fixed dose combination (FDC) tablets of canagliflozin and metformin immediate release (IR) in comparison with the individual components of the FDC tablets (canagliflozin and metformin IR).

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Tempe, Arizona, United States

About this study

This is an open-label (identity of study drug will be known to volunteer and study staff), single-center study to evaluate the bioequivalence (to see if blood levels of one drug are equivalent to blood levels of another drug) of canagliflozin and metformin IR when administered orally (by mouth) as individual components (ie, separate tablets of canagliflozin and metformin IR) (Treatment A) and when administered as FDC tablets (ie, canagliflozin and metformin IR contained in the same tablet) (Treatment B). Healthy volunteers participating in the study will be randomly (by chance) assigned to receive a single dose of Treatment A followed by a single dose of Treatment B or Treatment B followed by Treatment A with a period of approximately 15 days between treatments. The total duration of the study will be approximately 51 days.

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 18.5 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

Canagliflozin tablets

Drug

Type = exact number, unit = mg, number = 300, form = tablet, route = oral use. One canagliflozin tablet taken orally (by mouth) on Day 1 of Treatment Period 1.

Other names: Treatment A (Reference)

Metformin IR tablets

Drug

Type = exact number, unit = mg, number = 500, form = tablet, route = oral use. Two metformin IR tablets taken orally (by mouth) on Day 1 of Treatment Period 1.

Other names: Treatment A (Reference)

Canagliflozin/metformin IR FDC tablets

Drug

Type = exact number, unit = mg, number = 50/500, form = tablet, route = oral use. Two Canagliflozin/metformin IR FDC tablets taken orally on Day 1 of Treatment Period 2.

Other names: Treatment B (Test)

Primary outcomes

  1. Canagliflozin plasma concentrations

    Time frame: Up to 72 hours in Treatment Period 1 and Treatment Period 2

  2. Metformin plasma concentrations

    Time frame: Up to 24 hours in Treatment Period 1 and Treatment Period 2

Secondary outcomes

  1. Changes in clinical laboratory test values

    Time frame: Up to approximately 51 days (includes from time of screening through study completion including the washout interval)

  2. Changes in vital signs measurements

    Time frame: Up to approximately 51 days (includes from time of screening through study completion including the washout interval)

  3. Changes in electrocardiogram (ECG) parameters

    Time frame: Up to approximately 51 days (includes from time of screening through study completion including the washout interval)

  4. Changes in physical examination results

    Time frame: Up to approximately 51 days (includes from time of screening through study completion including the washout interval)

  5. The number of patients reporting adverse events

    Time frame: Up to approximately 51 days (includes from time of screening through study completion including the washout interval)

Sponsors and collaborators

Lead sponsor

Janssen Research & Development, LLC

Industry

Registry information

Official study title

A Single-Dose, Open-Label, Randomized, 2-Way Crossover Pivotal Study to Assess the Bioequivalence of 2 FDC Tablets of Canagliflozin and Metformin IR (150 mg/500 mg) With Respect to the Individual Components of Canagliflozin (1x300 mg) and Metformin IR Tablets (2x500 mg) in Healthy Fed Subjects

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jan 11, 2012
Registry last updated
Jan 16, 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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