NCT02221180

Brief Summary

The purpose of this study is to evaluate the bioequivalence of metformin component of the canagliflozin and metformin immediate release (IR) fixed dose combination (FDC) tablet compared with the metformin IR tablet co-administered with canagliflozin in healthy fed and fasted participants.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Aug 2014

Shorter than P25 for phase_1

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

August 1, 2014

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

August 18, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 20, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

November 25, 2014

Status Verified

November 1, 2014

Enrollment Period

3 months

First QC Date

August 18, 2014

Last Update Submit

November 24, 2014

Conditions

Bioequivalence

Keywords

BioequivalenceMetforminCanagliflozinHealthy

Outcome Measures

Primary Outcomes (2)

  • Plasma Concentration of Metformin

    Plasma concentrations of metformin are used to evaluate how much metformin is in the blood over time.

    Pre-dose, up to 24 hours afterdose

  • Plasma Concentration of Canagliflozin

    Plasma concentrations of canagliflozin are used to evaluate how much canagliflozin is in the blood, 2 hours after dosing.

    2 hours after dosing

Secondary Outcomes (3)

  • Adverse Events

    Up to approximately 58 days

  • Clinical Laboratory Test

    Up to approximately 58 days

  • Vital Signs

    Up to approximately 58 days

Study Arms (4)

Treatment Sequence ABDC

EXPERIMENTAL

Treatment A (1 immediate release (IR) fixed dose combination \[FDC\] tablet containing canagliflozin 150 milligram \[mg\] and metformin 500 mg orally under fed condition) on Day 1 of treatment period 1, followed by Treatment B (1 canagliflozin tablet 50 mg and 1 canagliflozin tablet 100 mg along with 1 IR tablet of metformin 500 mg orally under fed condition) on Day 1 of treatment period 2, followed by Treatment D (1 canagliflozin tablet 50 mg and 1 canagliflozin tablet 100 mg along with 1 IR tablet of metformin 500 mg orally under fasted condition) on Day 1 of treatment period 3, then Treatment C (1 IR FDC tablet containing canagliflozin 150 mg and metformin 500 mg orally under fasted condition) on Day 1 of treatment period 4. A washout period of 7 days will be maintained between each treatment period.

Drug: Canagliflozin and Metformin Immediate Release (IR) Fixed Dose Combination [FDC]Drug: CanagliflozinDrug: Metformin

Treatment Sequence BCAD

EXPERIMENTAL

Treatment B (1 canagliflozin tablet 50 mg and 1 canagliflozin tablet 100 mg along with 1 IR tablet of metformin 500 mg orally under fed condition) on Day 1 of treatment period 1, followed by Treatment C (1 IR FDC tablet containing canagliflozin 150 mg and metformin 500 mg orally under fasted condition) on Day 1 of treatment period 2, followed by Treatment A (1 IR FDC tablet containing canagliflozin 150 mg and metformin 500 mg orally under fed condition) on Day 1 of treatment period 3, then Treatment D (1 canagliflozin tablet 50 mg and 1 canagliflozin tablet 100 mg along with 1 IR tablet of metformin 500 mg orally under fasted condition) on Day 1 of treatment period 4. A washout period of 7 days will be maintained between each treatment period.

Drug: Canagliflozin and Metformin Immediate Release (IR) Fixed Dose Combination [FDC]Drug: CanagliflozinDrug: Metformin

Treatment Sequence CDBA

EXPERIMENTAL

Treatment C (1 IR FDC tablet containing canagliflozin 150 mg and metformin 500 mg orally under fasted condition) on Day 1 of treatment period 1, followed by Treatment D (1 canagliflozin tablet 50 mg and 1 canagliflozin tablet 100 mg along with 1 IR tablet of metformin 500 mg orally under fasted condition) on Day 1 of treatment period 2, followed by Treatment B (1 canagliflozin tablet 50 mg and 1 canagliflozin tablet 100 mg along with 1 IR tablet of metformin 500 mg orally under fed condition) on Day 1 of treatment period 3, then Treatment A (1 IR FDC tablet containing canagliflozin 150 mg and metformin 500 mg orally under fed condition) on Day 1 of treatment period 4. A washout period of 7 days will be maintained between each treatment period.

Drug: Canagliflozin and Metformin Immediate Release (IR) Fixed Dose Combination [FDC]Drug: CanagliflozinDrug: Metformin

Treatment Sequence DACB

EXPERIMENTAL

Treatment D (1 canagliflozin tablet 50 mg and 1 canagliflozin tablet 100 mg along with 1 IR tablet of metformin 500 mg orally under fasted condition) on Day 1 of treatment period 1, followed by Treatment A (1 IR FDC tablet containing canagliflozin 150 mg and metformin 500 mg orally under fed condition) on Day 1 of treatment period 2, followed by Treatment C (1 IR FDC tablet containing canagliflozin 150 mg and metformin 500 mg orally under fasted condition) on Day 1 of treatment period 3, then Treatment B (1 canagliflozin tablet 50 mg and 1 canagliflozin tablet 100 mg along with 1 IR tablet of metformin 500 mg orally under fed condition) on Day 1 of treatment period 4. A washout period of 7 days will be maintained between each treatment period.

Drug: Canagliflozin and Metformin Immediate Release (IR) Fixed Dose Combination [FDC]Drug: CanagliflozinDrug: Metformin

Interventions

Canagliflozin and Metformin Immediate Release (IR) Fixed Dose Combination [FDC]DRUG

Participants will receive 1 IR FDC tablet containing canagliflozin 150 mg and metformin 500 mg orally under fed or fasted condition in each treatment period as per treatment sequence.

Also known as: CANA/MET IR FDC
Treatment Sequence ABDCTreatment Sequence BCADTreatment Sequence CDBATreatment Sequence DACB
CanagliflozinDRUG

Participants will receive canagliflozin 150 mg (50 mg+100 mg oral tablet) under fed or fasted condition in each treatment period as per treatment sequence.

Also known as: CANA
Treatment Sequence ABDCTreatment Sequence BCADTreatment Sequence CDBATreatment Sequence DACB
MetforminDRUG

Participants will receive metformin 500 mg tablet orally under fed or fasted condition in each treatment period as per treatment sequence.

Also known as: MET
Treatment Sequence ABDCTreatment Sequence BCADTreatment Sequence CDBATreatment Sequence DACB

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Body mass index (BMI) between 18.5 and 30 kilogram per square meter (kg/m\^2) (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 electrocardiogram (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

CanagliflozinMetformin

Intervention Hierarchy (Ancestors)

ThiophenesSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 1-RingHeterocyclic CompoundsGlucosidesGlycosidesCarbohydratesBiguanidesGuanidinesAmidines

Study Officials

  • Janssen Research & Development, LLC 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

August 18, 2014

First Posted

August 20, 2014

Study Start

August 1, 2014

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

November 25, 2014

Record last verified: 2014-11

Locations

US(1)