ClinicalTrials.Veeva

Menu

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

Johnson & Johnson (J&J) logo

Johnson & Johnson (J&J)

Status and phase

Completed
Phase 1

Conditions

Healthy

Treatments

Drug: Canagliflozin/Metformin

Study type

Interventional

Funder types

Industry

Identifiers

NCT01273571
28431754DIA1028
CR017815

Details and patient eligibility

About

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.

Full 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.

Enrollment

18 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

18 participants in 1 patient group

001
Experimental group
Description:
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.
Treatment:
Drug: Canagliflozin/Metformin

Trial contacts and locations

0

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems