NCT02077803

Brief Summary

The purpose of this study is to assess the bioequivalence (similarity of the drug amount in blood among the formulations) of the fixed dose combination (two components combined in one tablet) of canagliflozin and metformin extended release (XR) tablet (dose of 2 X 50 mg/1000 mg) with respect to the individual components of canagliflozin (1 x 100 mg) and metformin XR tablet (4 x 500 mg) in healthy fed participants.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
47

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Mar 2014

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

First Submitted

Initial submission to the registry

February 28, 2014

Completed
1 day until next milestone

Study Start

First participant enrolled

March 1, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 4, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

September 3, 2014

Status Verified

September 1, 2014

Enrollment Period

4 months

First QC Date

February 28, 2014

Last Update Submit

September 2, 2014

Conditions

Healthy

Keywords

HealthyCanagliflozinMetforminType 2 diabetes mellitusBioequivalenceGLUMETZA®

Outcome Measures

Primary Outcomes (2)

  • Plasma concentration of canagliflozin following the single dose of drug administration

    Plasma concentrations of canagliflozin are used to evaluate how long canagliflozin stays in the body.

    Day 1 to Day 2 (predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24 hours postdose); Day 3 (48 hour); and Day 4

  • Plasma concentration of metformin following the single dose of drug administration

    Plasma concentrations of metformin are used to evaluate how long it stays in the body.

    Day 1 to Day 2 (predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 14, 16, 24, and 30 hours postdose); and Day 3 (36 hours)

Secondary Outcomes (1)

  • Number of participants with adverse events as a measure of safety and tolerability

    Up to Day 10 of the follow-up period

Study Arms (3)

Treatment A

EXPERIMENTAL

Each participant will receive a single dose of 1 tablet of canagliflozin (CANA), 100 mg, and 4 tablets of metformin extended release (MET XR), 500 mg, administered together under fed conditions.

Drug: Canagliflozin, 100 mgDrug: Metformin XR, 500 mg

Treatment B

EXPERIMENTAL

Each participant will receive a single dose of 2 tablets of CANA/MET XR FDC, formulation 1, under fed conditions.

Drug: CANA/MET XR FDC, Formulation 1, 50 mg/1000 mg

Treatment C

EXPERIMENTAL

Each participant will receive a single dose of 2 tablets of CANA/MET XR FDC, formulation 2, under fed conditions.

Drug: CANA/MET XR FDC, Formulation 2, 50 mg/1000 mg

Interventions

Canagliflozin, 100 mgDRUG

Each tablet contains canagliflozin (CANA) of 100 mg to be taken orally (by mouth).

Treatment A
Metformin XR, 500 mgDRUG

Each tablet contains metformin extended release (MET XR), 500 mg, to be taken orally (by mouth).

Treatment A
CANA/MET XR FDC, Formulation 1, 50 mg/1000 mgDRUG

Each tablet contains 50 mg of canagliflozin and 1000 mg of metformin HCl granulate, formulation 1, to be taken orally.

Treatment B
CANA/MET XR FDC, Formulation 2, 50 mg/1000 mgDRUG

Each tablet contains 50 mg of canagliflozin and 1000 mg of metformin HCl granulate, formulation 2, to be taken orally.

Treatment C

Eligibility Criteria

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

You may qualify if:

  • Must sign an informed consent document indicating they understand the purpose of the study and procedures
  • Must have a body mass index (BMI) of between 18 and 30 kg/m², inclusive
  • Must have a body weight of not less than 50 kg
  • Must have a blood pressure between 90 and 140 mmHg inclusive, systolic, and no higher than 90 mmHg diastolic at screening
  • Must have normal renal function and no evidence of kidney damage (including abnormalities in blood or urine tests)

You may not qualify if:

  • History of or current clinically significant medical illness
  • Use of any prescription or nonprescription medication (including vitamins and herbal supplements)
  • History of clinically significant allergies, especially known hypersensitivity or intolerance to drugs or lactose
  • Known allergy to heparin or history of heparin induced thrombocytopenia
  • Donated blood or blood products or had substantial loss of blood within 3 months before screening

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Tempe, Arizona, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Canagliflozin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

ThiophenesSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 1-RingHeterocyclic CompoundsGlucosidesGlycosidesCarbohydrates

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

February 28, 2014

First Posted

March 4, 2014

Study Start

March 1, 2014

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

September 3, 2014

Record last verified: 2014-09

Locations

US(1)