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

NCT01273571 | Completed Phase 1

• 2 other identifiers: CR01781528431754DIA1028
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Healthy

Keywords

Canagliflozin; Metformin (GLUCOPHAGE IR); Pharmacokinetics; Pharmacodynamics

Outcome Measures

Primary Outcomes (5)

• Plasma concentrations of canagliflozin

  At protocol-specified times up to Day 11

• Plasma concentrations of metformin

  At protocol-specified times up to Day 11)

• Urine concentrations of metformin

  At protocol-specified times up to Day 10)

• Plasma concentrations of glucose

  Up to Day 9

• Urinary glucose excretion (UGE)

  Up to Day 11

Secondary Outcomes (1)

• The number and type of adverse events reported

  Up to Day 8

Study Arms (1)

001

EXPERIMENTAL

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.

Drug: Canagliflozin/Metformin

Interventions

Canagliflozin/Metformin DRUG

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.

001

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: lead

Related Publications (1)

• Devineni D, Manitpisitkul P, Murphy J, Skee D, Wajs E, Mamidi RN, Tian H, Vandebosch A, Wang SS, Verhaeghe T, Stieltjes H, Usiskin K. Effect of canagliflozin on the pharmacokinetics of glyburide, metformin, and simvastatin in healthy participants. Clin Pharmacol Drug Dev. 2015 May-Jun;4(3):226-36. doi: 10.1002/cpdd.166. Epub 2014 Oct 27.

  PMID: 27140803 DERIVED

MeSH Terms

Interventions

Canagliflozin; Metformin

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Glucosides; Glycosides; Carbohydrates; Biguanides; Guanidines; Amidines

Study Officials

• Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

  Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2010
• First Posted: January 10, 2011
• Study Start: December 1, 2010
• Study Completion: February 1, 2011
• Last Updated: July 29, 2013

Record last verified: 2013-07