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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

January 9, 2012
January 30, 2013
January 2012
March 2012   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01508195 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Study of Canagliflozin and Metformin Immediate Release (50 mg/500 mg) FDC Tablets in Healthy Volunteers
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

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).

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Healthy
  • 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)
  • 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)
  • 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.
    Interventions:
    • Drug: Canagliflozin tablets
    • Drug: Metformin IR tablets
    • Drug: Canagliflozin/metformin IR FDC tablets
  • 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.
    Interventions:
    • Drug: Canagliflozin/metformin IR FDC tablets
    • Drug: Canagliflozin tablets
    • Drug: Metformin IR tablets
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
64
March 2012
March 2012   (final data collection date for primary outcome measure)

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
Both
19 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01508195
CR100684, 28431754DIA1046
Not Provided
Janssen Research & Development, LLC
Janssen Research & Development, LLC
Not Provided
Study Director: Janssen Research & Development, LLC L.L.C Clinical Trial Janssen Research & Development, LLC
Janssen Research & Development, LLC
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP