NCT02220218

Brief Summary

The purpose of this study to evaluate the bioequivalence (is the amount same in both the pills) 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 tablet 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 healthy

Timeline
Completed

Started Aug 2014

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

August 1, 2014

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

August 18, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 19, 2014

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

November 19, 2014

Status Verified

November 1, 2014

Enrollment Period

2 months

First QC Date

August 18, 2014

Last Update Submit

November 18, 2014

Conditions

Healthy

Keywords

HealthyMetforminCanagliflozinJNJ-28431754

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 post-dose

  • 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 Tests

    Up to approximately 58 days

  • Vital Signs

    Up to approximately 58 days

Study Arms (4)

Treatment Sequence ABDC

EXPERIMENTAL

Treatment A (canagliflozin and metformin immediate release \[IR\] fixed dose combination \[FDC\] tablet 50 milligram \[mg\]/500 mg orally under fed condition) on Day 1 of treatment period 1, followed by Treatment B (canagliflozin tablet 50 mg along with metformin IR tablet 500 mg orally under fed condition) on Day 1 of treatment period 2, followed by Treatment D (canagliflozin tablet 50 mg along with metformin IR tablet 500 mg orally under fasted condition) on Day 1 of treatment period 3, then Treatment C (canagliflozin and metformin IR FDC tablet 50 mg/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 + Metformin Immediate Release (IR) Fixed Dose Combination (FDC)Drug: CanagliflozinDrug: Metformin IR

Treatment Sequence BCAD

EXPERIMENTAL

Treatment B (canagliflozin tablet 50 mg along with metformin IR tablet 500 mg orally under fed condition) on Day 1 of treatment period 1, followed by Treatment C (canagliflozin and metformin IR FDC tablet 50 mg/500 mg orally under fasted condition) on Day 1 of treatment period 2, followed by Treatment A (canagliflozin and metformin IR FDC tablet 50 mg/500 mg orally under fed condition) on Day 1 of treatment period 3, then Treatment D (canagliflozin tablet 50 mg along with metformin IR tablet 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 + Metformin Immediate Release (IR) Fixed Dose Combination (FDC)Drug: CanagliflozinDrug: Metformin IR

Treatment Sequence CDBA

EXPERIMENTAL

Treatment C (canagliflozin and metformin IR FDC tablet 50 mg/500 mg orally under fasted condition) on Day 1 of treatment period 1, followed by Treatment D (canagliflozin tablet 50 mg along with metformin IR tablet 500 mg orally under fasted condition) on Day 1 of treatment period 2, followed by Treatment B (canagliflozin tablet 50 mg along with metformin IR tablet 500 mg orally under fed condition) on Day 1 of treatment period 3, then Treatment A (canagliflozin and metformin IR FDC tablet 50 mg/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 + Metformin Immediate Release (IR) Fixed Dose Combination (FDC)Drug: CanagliflozinDrug: Metformin IR

Treatment Sequence DACB

EXPERIMENTAL

Treatment D (canagliflozin tablet 50 mg along with metformin IR tablet 500 mg orally under fasted condition) on Day 1 of treatment period 1, followed by Treatment A (canagliflozin and metformin IR FDC tablet 50 mg/500 mg orally under fed condition) on Day 1 of treatment period 2, followed by Treatment C (canagliflozin and metformin IR FDC tablet 50 mg/500 mg orally under fasted condition) on Day 1 of treatment period 3, then Treatment B (canagliflozin tablet 50 mg along with metformin IR tablet 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 + Metformin Immediate Release (IR) Fixed Dose Combination (FDC)Drug: CanagliflozinDrug: Metformin IR

Interventions

Canagliflozin + Metformin Immediate Release (IR) Fixed Dose Combination (FDC)DRUG

Canagliflozin and metformin IR FDC tablet 50 mg/500 mg orally under fed or fasted conditions on Day 1 of any of the 4 treatment periods.

Treatment Sequence ABDCTreatment Sequence BCADTreatment Sequence CDBATreatment Sequence DACB
CanagliflozinDRUG

Canagliflozin tablet 50 mg orally under fed or fasted conditions on Day 1 of any of the 4 treatment periods.

Treatment Sequence ABDCTreatment Sequence BCADTreatment Sequence CDBATreatment Sequence DACB
Metformin IRDRUG

Metformin IR tablet 500 mg orally under fed or fasted conditions on Day 1 of any of the 4 treatment periods.

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 19, 2014

Study Start

August 1, 2014

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

November 19, 2014

Record last verified: 2014-11

Locations

US(1)