NCT01508195

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Jan 2012

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

January 9, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 11, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

January 31, 2013

Status Verified

January 1, 2013

Enrollment Period

2 months

First QC Date

January 9, 2012

Last Update Submit

January 30, 2013

Conditions

Healthy

Keywords

Healthy VolunteersBioequivalenceCanagliflozin (JNJ-28431754)Metformin IR

Outcome Measures

Primary Outcomes (2)

  • Canagliflozin plasma concentrations

    Up to 72 hours in Treatment Period 1 and Treatment Period 2

  • Metformin plasma concentrations

    Up to 24 hours in Treatment Period 1 and Treatment Period 2

Secondary Outcomes (5)

  • Changes in clinical laboratory test values

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

  • Changes in vital signs measurements

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

  • Changes in electrocardiogram (ECG) parameters

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

  • Changes in physical examination results

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

  • The number of patients reporting adverse events

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

Study Arms (2)

Treatment Sequence AB

EXPERIMENTAL

Treatment A (canaglifozin + metformin IR tablets) administered on Day 1 of Treatment Period 1 followed by Treatment B (canagliflozin/metformin IR FDC tablets) administered on Day 1 of Treatment Period 2 with a washout period of 10-15 days between treatment periods.

Drug: Canagliflozin tabletsDrug: Metformin IR tabletsDrug: Canagliflozin/metformin IR FDC tablets

Treatment Sequence BA

EXPERIMENTAL

Treatment B (canagliflozin/metformin IR FDC tablets) administered on Day 1 of Treatment Period 1 followed by Treatment A (canaglifozin + metformin IR tablets) administered on Day 1 of Treatment Period 2 with a washout period of 10-15 days between treatment periods.

Drug: Canagliflozin/metformin IR FDC tabletsDrug: Canagliflozin tabletsDrug: Metformin IR tablets

Interventions

Canagliflozin tabletsDRUG

Type = exact number, unit = mg, number = 100, form = tablet, route = oral use. One canagliflozin tablet taken orally (by mouth) on Day 1 of Treatment Period 1.

Also known as: Treatment A (Reference)
Treatment Sequence AB
Metformin IR tabletsDRUG

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.

Also known as: Treatment A (Reference)
Treatment Sequence AB
Canagliflozin/metformin IR FDC tabletsDRUG

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.

Also known as: Treatment B (Test)
Treatment Sequence AB

Eligibility Criteria

Age19 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Body mass index (BMI) between 18.5 and 30 kg/m² (inclusive) and a body weight of not less than 50 kg

You may not qualify if:

  • History of or current medical illness, abnormal values for hematology or clinical chemistry laboratory tests, or abnormal physical examination, vital signs or 12-lead ECG deemed to be clinically significant by the Investigator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Lincoln, Nebraska, United States

Location

MeSH Terms

Interventions

Canagliflozin

Intervention Hierarchy (Ancestors)

ThiophenesSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 1-RingHeterocyclic CompoundsGlucosidesGlycosidesCarbohydrates

Study Officials

  • Janssen Research & Development, LLC L.L.C Clinical Trial

    Janssen Research & Development, LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2012

First Posted

January 11, 2012

Study Start

January 1, 2012

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

January 31, 2013

Record last verified: 2013-01

Locations

US(1)