A Pharmacokinetic and Pharmacodynamic Study of Once-Daily and Twice-Daily Dosing With Canagliflozin in Healthy Adult Volunteers
| Status: | Archived |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | February 2011 |
| End Date: | April 2011 |
An Open-Label, Multiple-Dose Study to Assess the Steady-State Pharmacokinetics, Pharmacodynamics and Safety of Once-Daily Versus Twice-Daily Dosing With Canagliflozin in Healthy Subjects
The purpose of this study is to evaluate the effects of canagliflozin on glucose levels in
the blood and urine when taken at 2 dose levels as a once-daily or twice-daily dosing
regimen in healthy adult volunteers
This is an open-label (volunteers will know the names of treatments they are assigned),
single-center study of canagliflozin (JNJ-28431754) 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). Patients in
Cohort 1 will be randomized to receive Treatment A (one 300-mg tablet orally, by mouth [PO]
once daily for 5 days) followed 10 days later by Treatment B (one 50-mg and one 100-mg
tablet PO twice daily for 5 days) or Treatment B followed by Treatment A. Patients in Cohort
2 will be randomized to receive Treatment C (one 100-mg tablet PO once daily for 5 days)
followed 10 days later by Treatment D (one 50-mg tablet PO twice daily for 5 days) or
Treatment D followed by Treatment C.
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