Renal Impairment Clinical Trial
Official title:
A Clinical Study to Investigate the Pharmacokinetics/Pharmacodynamics and Tolerability of DA-1229(Evogliptin) Tablet in Renal Impaired Patients
| NCT number | NCT02214693 |
| Other study ID # | DA1229_RI_I |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 1 |
| First received | August 11, 2014 |
| Last updated | August 25, 2015 |
| Start date | July 2014 |
| Verified date | August 2015 |
| Source | Dong-A ST Co., Ltd. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Korea: Ministry of Food and Drug Safety |
| Study type | Interventional |
This is a clinical study to investigate the pharmacokinetics/pharmacodynamics and tolerability of DA-1229(Evogliptin) tabletin renal impaired patients.
| Status | Completed |
| Enrollment | 30 |
| Est. completion date | |
| Est. primary completion date | March 2015 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 20 Years to 70 Years |
| Eligibility |
Inclusion Criteria: - Age between 20 and 70 - Weights between 50 and 90kg(Female : 40 and 90kg) - Volunteer who totally understands the progress of this clinical trials, makes decision by his free will, and signed a consent form to follow the progress - Stable results of estimated GFR in 4 months recently Exclusion Criteria: - Volunteer who has past or present history of any diseases following below.(liver including hepatitis virus carrier, kidney, Neurology, immunology, pulmonary, endocrine, hematooncology, cardiology, mental disorder) - Volunteer who had drug(DPP-4 inhibitor) hypersensitivity reaction - Volunteer who already participated in other trials in 2 months - Volunteer who had whole blood donation in 2 months, or component blood donation in 1 months or transfusion |
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Clinical Trial Center, Seoul National University Hospital | Seoul |
| Lead Sponsor | Collaborator |
|---|---|
| Dong-A ST Co., Ltd. |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Area Under Curve(AUC) last | Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 60, 72, 96, 120h post-dose | No |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
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