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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01273571

Enrollment

Registered

2011-01-10

Start date

2010-12-31

Completion date

2011-02-28

Last updated

2013-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Canagliflozin, Metformin (GLUCOPHAGE IR), Pharmacokinetics, Pharmacodynamics

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.

Interventions

DRUGCanagliflozin/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 design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
The number and type of adverse events reported	Up to Day 8

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026