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

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ClinicalTrials.gov Identifier: NCT01459094
Recruitment Status : Completed
First Posted : October 25, 2011
Last Update Posted : February 20, 2013
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Brief Summary:
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 or disease Intervention/treatment 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

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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
Study Start Date : October 2011
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. Canagliflozin plasma concentrations [ Time Frame: Up to 72 hours ]
  2. Metformin plasma concentrations [ Time Frame: Up to 24 hours ]

Secondary Outcome Measures :
  1. Adverse events [ Time Frame: Up to approximately 22 days ]
    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).

  2. Clinical Laboratory Tests [ Time Frame: Up to approximately 22 days ]
    Clinically relevant changes from baseline occurring in laboratory safety parameters

  3. Vital Signs [ Time Frame: Up to approximately 22 days ]
    Changes from baseline in blood pressure and pulse



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01459094


Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
Study Director: Janssen Research & Development, LLC L.LC. Clinical Trial Janssen Research & Development, LLC

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT01459094     History of Changes
Other Study ID Numbers: CR100652
28431754DIA1037 ( Other Identifier: Janssen Research & Development, LLC )
First Posted: October 25, 2011    Key Record Dates
Last Update Posted: February 20, 2013
Last Verified: February 2013

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

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