A Pharmacokinetic and Pharmacodynamic Study of Metformin and Canagliflozin in Healthy Adult Volunteers
This study has been completed.
Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT01273571
First received: December 23, 2010
Last updated: March 12, 2012
Last verified: March 2012
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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 | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: Canagliflozin/Metformin |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
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 ]
Secondary Outcome Measures:
- The number and type of adverse events reported [ Time Frame: Up to Day 8 ] [ Designated as safety issue: No ]
| Enrollment: | 18 |
| Study Start Date: | December 2010 |
| Study Completion Date: | February 2011 |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
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.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01273571
Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Investigators
| Study Director: | Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
More Information
No publications provided
| Responsible Party: | Director, Clin Pharm Leader, Johnson & Johnson Pharmaceutical Research and Development, L.L.C. |
| ClinicalTrials.gov Identifier: | NCT01273571 History of Changes |
| Other Study ID Numbers: | CR017815, 28431754DIA1028 |
| Study First Received: | December 23, 2010 |
| Last Updated: | March 12, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
|
Canagliflozin Metformin (GLUCOPHAGE IR) Pharmacokinetics Pharmacodynamics |
Additional relevant MeSH terms:
|
Metformin Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013