Effect of Food on a Fixed Dose Combination Tablet of Canagliflozin and Metformin Immediate Release in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT01459094
First received: October 21, 2011
Last updated: February 18, 2013
Last verified: February 2013
  Purpose

The purpose of this study is to see if the absorption and distribution of a fixed-dose Combination (FDC) tablet of canagliflozin and metformin IR is affected when taken with food by healthy volunteers.


Condition Intervention Phase
Healthy
Drug: A (CANA/MET IR FDC tablet - fasting state) / B (CANA/MET IR FDC tablet - fed state)
Drug: B (CANA/MET IR FDC tablet - fed state) / A (CANA/MET IR FDC tablet - fasting state)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Single-Dose, Open-Label, Randomized, 2-Period Crossover Study to Assess the Effect of Food Coadministration on the Pharmacokinetics of a Fixed Dose Combination Tablet of Canagliflozin and Metformin Immediate Release in Healthy 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 approximately 22 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 10-14 day washout period between treatment periods (total time is approximately 22 days).

  • Clinical Laboratory Tests [ Time Frame: Up to approximately 22 days ] [ Designated as safety issue: No ]
    Clinically relevant changes from baseline occurring in laboratory safety parameters

  • Vital Signs [ Time Frame: Up to approximately 22 days ] [ Designated as safety issue: No ]
    Changes from baseline in blood pressure and pulse


Enrollment: 24
Study Start Date: October 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 Drug: A (CANA/MET IR FDC tablet - fasting state) / B (CANA/MET IR FDC tablet - fed state)
Treatment A: Type = 1, unit = mg, number = 150/1000, form = tablet, route = oral use. One CANA/MET IR FDC tablet taken orally (by mouth) in a fasting state on Day 1 of Treatment Period 1 followed 10-14 days later by Treatment B: Type = 1, unit = mg, number = 150/1000, form = tablet, route = oral use. One CANA/MET IR FDC tablet taken orally in a fed state on Day 1 of Treatment Period 2.
Experimental: Treatment Sequence BA Drug: B (CANA/MET IR FDC tablet - fed state) / A (CANA/MET IR FDC tablet - fasting state)
Treatment B: Type = 1, unit = mg, number = 150/1000, form = tablet, route = oral use. One CANA/MET IR FDC tablet taken orally in a fed state on Day 1 of Treatment Period 1 followed 10-14 days later by Treatment B: Type = 1, unit = mg, number = 150/1000, form = tablet, route = oral use. One CANA/MET IR FDC tablet taken orally in a fasting state on Day 1 of Treatment Period 2.

Detailed Description:

This is an open-label (identity of study drug will be known to volunteers and study staff), single-center study to evaluate the oral bioavailability (ie, absorption and distribution within the body) and pharmacokinetics (blood levels) of a single dose of 1 fixed-dose combination (FDC) tablet of canagliflozin and metformin IR (abbreviated as 1 CANA/MET IR FDC tablet) when taken by healthy volunteers without food (in a fasting state) or with food (in a fed state). Healthy volunteers participating in the study will be randomly (by chance) assigned to receive Treatment A (1 CANA/MET IR FDC tablet taken by healthy volunteers in a fasting state) followed approximately 14 days later by Treatment B (1 CANA/MET IR FDC tablet taken by healthy volunteers in a fed state) or Treatment B followed approximately 14 days later by Treatment A.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria: - Body mass index (BMI) between 18 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: NCT01459094

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: NCT01459094     History of Changes
Other Study ID Numbers: CR100652, 28431754DIA1037
Study First Received: October 21, 2011
Last Updated: February 18, 2013
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on September 16, 2014