Multiple Dose Pharmacokinetics of Canagliflozin/Metformin 150/1,000 mg Fixed Dose Combination

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02039245
Recruitment Status : Completed
First Posted : January 17, 2014
Last Update Posted : April 2, 2014
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Brief Summary:
The purpose of this study is to evaluate the multiple dose pharmacokinetics of 2 Canagliflozin/extended release Metformin (CANA/MET XR) fixed dose combination tablets (150 mg/1,000 mg each) following once-daily oral dosing in healthy participants.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: CANA/MET XR FDC Phase 1

Detailed Description:
This is an open-label (physicians and participants know the identity of the assigned treatment), multiple-dose, single-center, pharmacokinetic study of a fixed dose combination (FDC) of 150 mg/1,000 mg Canagliflozin/extended release Metformin (CANA/MET XR) tablets. The study will consist of 3 phases: a Screening Phase of approximately 3 weeks, an Open-Label Treatment Phase, (when the participants will be confined to the study center for 11 days), and a Follow-up Phase of about 10 days. The total duration of the study will be about 42 days for each participant. During the Open-Label Treatment Phase, approximately 12 healthy adult participants will receive a single oral dose of 2 CANA/MET XR tablets once daily for 7 days after a provided dinner. Participants will be required to fast from the end of lunch until the dinner (a period of at least 6.5 hours) on Days 1 and 7 only.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Study to Evaluate the Multiple Dose Pharmacokinetics of Canagliflozin (JNJ-28431754) and Metformin Following Once-Daily Administration of 2 Canagliflozin/Metformin XR (150/1,000-mg) Fixed Dose Combination Tablets in Healthy Subjects
Study Start Date : January 2014
Actual Primary Completion Date : February 2014
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Canagliflozin/Metformin XR
Each patient will receive 2 tablets of CANA/MET XR combination of total dose 300/2000 mg
Each tablet contains Canagliflozin/extended release Metformin (CANA/MET XR) fixed dose combination (FDC) of 150 mg/1,000 mg, to be taken orally (by mouth)

Primary Outcome Measures :
  1. Plasma concentration of canagliflozin following the dose of 2 CANA/MET XR FDC tablets [ Time Frame: Day 1, Day 7 ]
    Plasma concentrations of canagliflozin are used to evaluate how long canagliflozin stays in the body.

  2. Plasma concentration of metformin following the dose of 2 CANA/MET XR FDC tablets [ Time Frame: Day 1, Day 7 ]
    Plasma concentrations of metformin are used to evaluate how long it stays in the body.

Secondary Outcome Measures :
  1. Percentage of participants with adverse events as a measure of safety and tolerability [ Time Frame: Screening, up to Day 10 of the follow-up ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Must sign an informed consent document indicating they understand the purpose of the study and procedures
  • Must have a body mass index (BMI) of between 18 and 30 kg/m², inclusive
  • Must have a body weight of not less than 50 kg
  • Must have a blood pressure between 90 and 140 mmHg inclusive, systolic, and no higher than 90 mmHg diastolic at screening
  • Must have normal renal function and no evidence of kidney damage (including abnormalities in blood or urine tests)

Exclusion Criteria:

  • History of or current clinically significant medical illness
  • Use of any systemic prescription or nonprescription medication (including vitamins and herbal supplements)
  • Known allergy to canagliflozin or metformin or any of the excipients of the formulation
  • Known allergy to heparin or history of heparin induced thrombocytopenia
  • History of smoking or use of nicotine-containing substances within the previous 2 months

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 identifier (NCT number): NCT02039245

United States, New Jersey
Neptune, New Jersey, United States
Sponsors and Collaborators
Janssen Research & Development, LLC
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC

Responsible Party: Janssen Research & Development, LLC Identifier: NCT02039245     History of Changes
Other Study ID Numbers: CR103255
28431754DIA1042 ( Other Identifier: Janssen Research & Development, LLC )
First Posted: January 17, 2014    Key Record Dates
Last Update Posted: April 2, 2014
Last Verified: April 2014

Keywords provided by Janssen Research & Development, LLC:
Healthy Volunteers
Type 2 Diabetes Mellitus

Additional relevant MeSH terms:
Hypoglycemic Agents
Physiological Effects of Drugs