A Study to Assess the Bioequivalence of Fixed Dose Combination (FDC) 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:
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT01463228
First received: October 7, 2011
Last updated: August 21, 2012
Last verified: August 2012
  Purpose

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


Condition Intervention Phase
Healthy
Drug: A (canagliflozin and metformin IR individual tablets) / B (canagliflozin/metformin IR FDC tablets)
Drug: B (canagliflozin/metformin IR FDC tablets / A (canagliflozin and metformin IR individual 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: A Single-Dose, Open-Label, Randomized, 2-Way Crossover Pivotal Study to Assess the Bioequivalence of FDC Tablets of Canagliflozin and Metformin IR (2x150 mg/1000 mg) With Respect to the Individual Components of Canagliflozin (1x300 mg) and Metformin IR (2x1000 mg) Tablets in Healthy Fed Subjects

Resource links provided by NLM:


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 24 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).

  • Clinical Laboratory Tests [ 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 ]

Enrollment: 83
Study Start Date: September 2011
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment Sequence AB Drug: A (canagliflozin and metformin IR individual tablets) / B (canagliflozin/metformin IR FDC tablets)
Treatment A: Canagliflozin: Type = 1, unit = mg, number = 300, form = tablet, route = oral use + metformin IR: Type = 2, unit = mg, number = 1000, form = tablet, route = oral use. One canagliflozin tablet and 2 metformin IR tablets taken orally (by mouth) on Day 1 of Treatment Period 1 followed 10-15 days later by Treatment B (canagliflozin/metformin IR FDC): Type = 2, unit = mg, number = 150/1000, form = tablet, route = oral use. Two canagliflozin/metformin IR FDC tablets taken orally on Day 1 of Treatment Period 2
Experimental: Treatment Sequence BA Drug: B (canagliflozin/metformin IR FDC tablets / A (canagliflozin and metformin IR individual tablets)
Treatment B (canagliflozin/metformin IR FDC): Type = 2, unit = mg, number = 150/1000, form = tablet, route = oral use. Two Canagliflozin/metformin IR FDC tablets taken orally on Day 1 of Treatment Period 1 followed 10-15 days later by Treatment A: Canagliflozin: Type = 1, unit = mg, number = 300, form = tablet, route = oral use + Metformin IR: Type = 2, unit = mg, number = 1000, form = tablet, route = oral use. One canagliflozin tablet and 2 metformin IR tablets taken orally (by mouth) on Day 1 of Treatment Period 2.

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 IR when administered orally (by mouth) as individual components (ie, separate tablets of canagliflozin and metformin IR) (Treatment A) and when administered as a fixed dose combination (FDC) tablet (ie, canagliflozin and metformin IR 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01463228

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: DIRECTOR, CLIN PHARM LEADER, Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT01463228     History of Changes
Other Study ID Numbers: CR100636, 28431754DIA1038
Study First Received: October 7, 2011
Last Updated: August 21, 2012
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on July 23, 2014