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A Study of Canagliflozin and Metformin Immediate Release (50 mg/500 mg) FDC Tablets in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT01508195
First received: January 9, 2012
Last updated: January 30, 2013
Last verified: January 2013
History of Changes
  Purpose

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


Condition Intervention Phase
Healthy
 Drug: Canagliflozin tablets
Drug: Metformin IR tablets
Drug: Canagliflozin/metformin IR FDC 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 2 FDC Tablets of Canagliflozin and Metformin IR (50 mg/500 mg) With Respect to the Individual Components of Canagliflozin (1 x 100 mg) and Metformin IR Tablets (2 x 500 mg) in Healthy Fed Subjects

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 in Treatment Period 1 and Treatment Period 2 ] [ Designated as safety issue: No ]
  • Metformin plasma concentrations [ Time Frame: Up to 24 hours in Treatment Period 1 and Treatment Period 2 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in clinical laboratory test values [ Time Frame: Up to approximately 51 days (includes from time of screening through study completion including the washout interval) ] [ Designated as safety issue: No ]
  • Changes in vital signs measurements [ Time Frame: Up to approximately 51 days (includes from time of screening through study completion including the washout interval) ] [ Designated as safety issue: No ]
  • Changes in electrocardiogram (ECG) parameters [ Time Frame: Up to approximately 51 days (includes from time of screening through study completion including the washout interval) ] [ Designated as safety issue: No ]
  • Changes in physical examination results [ Time Frame: Up to approximately 51 days (includes from time of screening through study completion including the washout interval) ] [ Designated as safety issue: No ]
  • The number of patients reporting adverse events [ Time Frame: Up to approximately 51 days (includes from time of screening through study completion including the washout interval) ] [ Designated as safety issue: No ]

Enrollment: 64
Study Start Date: January 2012
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment Sequence AB
Treatment A (canaglifozin + metformin IR tablets) administered on Day 1 of Treatment Period 1 followed by Treatment B (canagliflozin/metformin IR FDC tablets) administered on Day 1 of Treatment Period 2 with a washout period of 10-15 days between treatment periods.
 Drug: Canagliflozin tablets
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 1.
Other Name: Treatment A (Reference)
Drug: Metformin IR tablets
Type = exact number, unit = mg, number = 500, form = tablet, route = oral use. Two metformin IR tablets taken orally (by mouth) on Day 1 of Treatment Period 1.
Other Name: Treatment A (Reference)
Drug: Canagliflozin/metformin IR FDC tablets
Type = exact number, unit = mg, number = 50/500, form = tablet, route = oral use. Two Canagliflozin/metformin IR FDC tablets taken orally on Day 1 of Treatment Period 2.
Other Name: Treatment B (Test)
Experimental: Treatment Sequence BA
Treatment B (canagliflozin/metformin IR FDC tablets) administered on Day 1 of Treatment Period 1 followed by Treatment A (canaglifozin + metformin IR tablets) administered on Day 1 of Treatment Period 2 with a washout period of 10-15 days between treatment periods.
 Drug: Canagliflozin/metformin IR FDC tablets
Type = exact number, unit = mg, number = 50/500, form = tablet, route = oral use. Two Canagliflozin/metformin IR FDC tablets taken orally on Day 1 of Treatment Period 1.
Other Name: Treatment B (Test)
Drug: Canagliflozin tablets
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 2.
Other Name: Treatment A (Reference)
Drug: Metformin IR tablets
Type = exact number, unit = mg, number = 500, form = tablet, route = oral use. Two metformin IR tablets taken orally (by mouth) on Day 1 of Treatment Period 2.
Other Name: Treatment A (Reference)

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 (to see if blood levels of one drug are equivalent to blood levels of another drug) 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 FDC tablets (ie, canagliflozin and metformin IR contained in the same tablet) (Treatment B). Healthy volunteers participating in the study will be randomly (by chance) assigned to receive a single dose of Treatment A followed by a single dose of Treatment B or Treatment B followed by Treatment A with a washout period of approximately 15 days between treatments. The total duration of the study will be approximately 51 days.

  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 ECG deemed to be clinically significant by the Investigator
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01508195

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

No publications provided

Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT01508195     History of Changes
Other Study ID Numbers: CR100684, 28431754DIA1046
Study First Received: January 9, 2012
Last Updated: January 30, 2013
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 May 23, 2013