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A Study to Assess the Bioequivalence of 2 Fixed Dose Combination Tablets of Canagliflozin and Metformin Immediate Release (IR) With Respect to the Individual Components of Canagliflozin and Metformin IR Tablets in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT01463774
First received: September 20, 2011
Last updated: November 20, 2012
Last verified: November 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Healthy
 Drug: Treatment A: Canagliflozin tablet
Drug: Treatment A: Metformin IR tablets
Drug: Treatment B: Canagliflozin/metformin fixed dose combination tablets
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pivotal BE CANA/MET IR FDC - Low Strength

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Janssen Research & Development, LLC:

Primary Outcome Measures:
  • Canagliflozin plasma concentrations [ Time Frame: Up to 72 hours ] [ Designated as safety issue: No ]
  • Metformin plasma concentrations [ Time Frame: Up to 72 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse events [ Time Frame: Up to approxmately 23 days ] [ Designated as safety issue: No ]
    The number and type of adverse events will be reported from Day 1 of treatment period 1 through 7-10 days after treatment period 2 including the 10-15 washout period between treatment periods (total time is approximately 23 days).

  • Changes from baseline in clinical laboratory test results [ Time Frame: Up to approximately 23 days ] [ Designated as safety issue: No ]
  • Vital Signs [ Time Frame: Up to approximately 23 days ] [ Designated as safety issue: No ]
    Blood pressure, pulse, and oral body temperature


Enrollment: 74
Study Start Date: September 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment Sequence AB
The study consists of 2 treatment periods (A and B). Each treatment period wiill be separated by a washout period of 10-15 days.
 Drug: Treatment A: Canagliflozin tablet
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 A.
Drug: Treatment A: Metformin IR tablets
Type=exact number, unit=mg, number=850, form=tablet, route=oral use. Two metformin IR tablets taken orally (by mouth) on Day 1 of Treatment Period A.
Drug: Treatment B: Canagliflozin/metformin fixed dose combination tablets
Type=exact number, unit=mg, number=50/850, form=tablet, route=oral use. Two canagliflozin/metformin IR tablets taken orally (by mouth) on Day 1 of Treatment Period B.
Experimental: Treatment Sequence BA
The study consists of 2 treatment periods (A and B). Each treatment period wiill be separated by a washout period of 10-15 days.
 Drug: Treatment A: Canagliflozin tablet
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 A.
Drug: Treatment A: Metformin IR tablets
Type=exact number, unit=mg, number=850, form=tablet, route=oral use. Two metformin IR tablets taken orally (by mouth) on Day 1 of Treatment Period A.
Drug: Treatment B: Canagliflozin/metformin fixed dose combination tablets
Type=exact number, unit=mg, number=50/850, form=tablet, route=oral use. Two canagliflozin/metformin IR tablets taken orally (by mouth) on Day 1 of Treatment Period B.

Detailed Description:

This is an open-label (identity of study drug will be known to volunteer and study staff), single-center study to evaluate the bioequivalence of canagliflozin and metformin when administered orally (by mouth) as individual components (ie, separate tablets of canagliflozin and metformin) (Treatment A) and when administered as a fixed dose combination tablet (ie, canagliflozin and metformin in the same tablet) (Treatment B). Healthy volunteers participating in the study will be randomly (by chance) assigned to receive Treatment A followed by Treatment B or Treatment B followed by Treatment A with a period of approximately 15 days between treatments.

  Eligibility

Ages Eligible for Study:   19 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01463774

Locations
United States, Nebraska
Lincoln, Nebraska, United States
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
Study Director: Janssen Research & Development, LLC L.LC. Clinical Trial Janssen Research & Development, LLC
  More Information

No publications provided

Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT01463774     History of Changes
Other Study ID Numbers: CR100674, 28431754DIA1039
Study First Received: September 20, 2011
Last Updated: November 20, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Janssen Research & Development, LLC:
Healthy Volunteers
Bioequivalence
Canagliflozin (JNJ-28431754)
Metformin

Additional relevant MeSH terms:
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013