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

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

Overview[ - collapse ][ - ]

Purpose	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.
Condition	Healthy
Intervention	Drug: Canagliflozin/Metformin
Phase	Phase 1
Sponsor	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Responsible Party	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier	NCT01273571
First Received	December 23, 2010
Last Updated	July 26, 2013
Last verified	July 2013

Tracking Information[ + expand ][ + ]

First Received Date	December 23, 2010
Last Updated Date	July 26, 2013
Start Date	December 2010
Estimated Primary Completion Date	February 2011
Current Primary Outcome Measures	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]
Current Secondary Outcome Measures	The number and type of adverse events reported [Time Frame: Up to Day 8] [Designated as safety issue: No]

Descriptive Information[ + expand ][ + ]

Brief Title	A Pharmacokinetic and Pharmacodynamic Study of Metformin and Canagliflozin in Healthy Adult Volunteers
Official Title	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
Brief Summary	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.
Detailed Description	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.
Study Type	Interventional
Study Phase	Phase 1
Study Design	Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Condition	Healthy
Intervention	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.
Study Arm (s)	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.

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	18
Estimated Completion Date	February 2011
Estimated Primary Completion Date	Not Provided
Eligibility Criteria	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.
Gender	Both
Ages	18 Years
Accepts Healthy Volunteers	Accepts Healthy Volunteers
Contacts	Not Provided
Location Countries	Not Provided

Administrative Information[ + expand ][ + ]

NCT Number	NCT01273571
Other Study ID Numbers	CR017815
Has Data Monitoring Committee	Not Provided
Information Provided By	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study Sponsor	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborators	Not Provided
Investigators	Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Verification Date	July 2013