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

• 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 ]

• 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 ]

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.

• 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

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