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A Pharmacokinetic and Pharmacodynamic Study of Metformin and Canagliflozin in Healthy Adult Volunteers

This study has been completed.
Sponsor:
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT01273571
First received: December 23, 2010
Last updated: March 12, 2012
Last verified: March 2012
History of Changes

December 23, 2010
March 12, 2012
December 2010
Not Provided
  • Plasma concentrations of canagliflozin [ Time Frame: At protocol-specified times up to Day 11 ] [ Designated as safety issue: No ]
  • Plasma concentrations of metformin [ Time Frame: At protocol-specified times up to Day 11) ] [ Designated as safety issue: No ]
  • Urine concentrations of metformin [ Time Frame: At protocol-specified times up to Day 10) ] [ Designated as safety issue: No ]
  • Plasma concentrations of glucose [ Time Frame: Up to Day 9 ] [ Designated as safety issue: No ]
  • Urinary glucose excretion (UGE) [ Time Frame: Up to Day 11 ] [ Designated as safety issue: No ]
  • Plasma concentrations of canagliflozin [ Time Frame: At protocol-specified times for 7 days (Days 5 through 11) ] [ Designated as safety issue: No ]
  • Plasma concentrations of metformin [ Time Frame: At protocol-specified times for 8 days (Days 1, 2, 3, 4, 8, 9, 10, and 11) ] [ Designated as safety issue: No ]
  • Urine concentrations of metformin [ Time Frame: At protocol-specified times for 6 days (Days 1, 2, 3, 8, 9, and 10) ] [ Designated as safety issue: No ]
  • Plasma concentrations of glucose [ Time Frame: On Days 1, 2, 7, 8, and 9 ] [ Designated as safety issue: No ]
  • Urinary glucose excretion (UGE) [ Time Frame: On Day 1 and Days 8 to 11 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01273571 on ClinicalTrials.gov Archive Site
The number and type of adverse events reported [ Time Frame: Up to Day 8 ] [ Designated as safety issue: No ]
The number and type of adverse events reported [ Time Frame: Day 1 up to 7-10 days after Day 8 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Pharmacokinetic and Pharmacodynamic Study of Metformin and Canagliflozin in Healthy Adult Volunteers
An Open-Label, Fixed Sequence Study to Investigate the Potential for Pharmacokinetic and Pharmacodynamic Interaction Between Single-Dose Metformin and Multiple-Dose Canagliflozin in Healthy Subjects

The purpose of the study is to investigate the potential interaction between multiple oral doses of canagliflozin and a single oral dose of metformin in healthy adult volunteers.

This is an open-label (volunteers will know the names of treatments they are assigned) single-center study of canagliflozin and metformin in healthy adult volunteers. Canagliflozin (a Sodium-Glucose Cotransporter 2 inhibitor) is currently under development to lower blood sugar levels in patients with type 2 diabetes mellitus (T2DM) and metformin is an approved treatment for patients with T2DM. Canagliflozin will be administered orally (by mouth) as a single 300-mg tablet on Days 4, 5, 6, 7, and 8 and metformin will be administered orally as two 1,000 mg tablets on Days 1 and 8. Both canagliflozin and metformin tablets will be taken with 8 ounces (240 mL) of water.
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Healthy
Drug: Canagliflozin/Metformin
Two 1000-mg tablets of metformin on Day 1 followed by one 300-mg tablet of canagliflozin once daily on Days 4 through 8, followed by two 1000-mg tablets of metformin and one 300-mg tablet of canagliflozin on Day 8.
Experimental: 001
Canagliflozin/Metformin Two 1000-mg tablets of metformin on Day 1 followed by one 300-mg tablet of canagliflozin once daily on Days 4 through 8 followed by two 1000-mg tablets of metformin and one 300-mg tablet of canagliflozin on Day 8.
Intervention: Drug: Canagliflozin/Metformin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
February 2011
Not Provided

Inclusion Criteria:

  • Healthy volunteers with a body mass index (BMI, a measure of a person's weight in relation to height) between 18 and 30 kg/m2, inclusive.

Exclusion Criteria:

  • History of or current clinically significant medical illness as determined by the Investigator
  • History of clinically significant allergies, especially known hypersensitivity or intolerance to lactose
  • Known allergy to canagliflozin or metformin or any of the excipients of the formulation of canagliflozin or metformin
  • Known allergy to heparin or history of heparin induced thrombocytopenia.
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01273571
CR017815, 28431754DIA1028
Not Provided
Director, Clin Pharm Leader, Johnson & Johnson Pharmaceutical Research and Development, L.L.C.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Not Provided
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
March 2012

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