Assessment of the Skin-concentration of Vildagliptin 50 mg Every 12 Hours for 10 Days in Healthy Subjects and Patients With Type 2 Diabetes
| Status: | Terminated |
|---|---|
| Conditions: | Diabetes, Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 30 - 65 |
| Updated: | 4/21/2016 |
| Start Date: | February 2008 |
An Open-label, Multiple Dose Study to Assess the Steady-state Skin Concentrations and Pharmacokinetics of Vildagliptin 50 mg BID for 10 Days in Healthy Subjects and Patients With Type 2 Diabetes
This study will look at the skin accumulation of vildagliptin and its two major metabolites,
LAY151 and LAF237-O-Glucuronide, after vildagliptin 50 mg given orally twice a day for 10
days in both healthy volunteers and patients with type 2 diabetes.
LAY151 and LAF237-O-Glucuronide, after vildagliptin 50 mg given orally twice a day for 10
days in both healthy volunteers and patients with type 2 diabetes.
Inclusion Criteria:
- Healthy volunteers and patients with type 2 diabetes
- Non-smoking, Caucasian and African American, male and female (postmenopausal,
surgically sterile or using double-barrier method of contraception) subjects between
30 and 65 years of age (inclusive)
- Type 2 diabetics on metformin and/or sufonylurea
Exclusion Criteria:
- History of type 1 diabetes or insulin use
- History of coagulation abnormalities
- History of abnormal heart conditions
- Pregnancy or breastfeeding
Other protocol-defined inclusion/exclusion criteria may apply
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