A Pharmacokinetic and Pharmacodynamic Study of Metformin and Canagliflozin in Healthy Adult Volunteers
- Conditions
- Healthy
- Interventions
- Drug: Canagliflozin/Metformin
- Registration Number
- NCT01273571
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 18
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 001 Canagliflozin/Metformin 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method The number and type of adverse events reported Up to Day 8