Healthy Clinical Trial
Official title:
DP-R212 Pharmacokinetic Study Pharmacokinetic Characteristics of DP-R212 in Comparison to Each Component Coadministered in Healthy Volunteers
An open label, randomized, 2-sequence, 2-period, single-dose cross-over study to evaluate the pharmacokinetics characteristics of DP-R212
| Status | Not yet recruiting |
| Enrollment | 36 |
| Est. completion date | September 2016 |
| Est. primary completion date | September 2016 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 19 Years to 45 Years |
| Eligibility |
Inclusion Criteria: - BMI 17.5~30.5 - signed the informed consent form prior to the study participation Exclusion Criteria: - Clinically significant disease - Previously donate whole blood within 60 days or component blood within 30 days - Clinically significant allergic disease - Taken IP in other trial within 90 days - An impossible one who participates in clinical trial by investigator's decision including laboratory test result |
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Alvogen Korea |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | AUClast | 0,0.5,1, 2, 3, 4, 5, 6, 8, 10, 12, 24,48,72 hr | No | |
| Primary | Cmax | 0,0.5,1, 2, 3, 4, 5, 6, 8, 10, 12, 24,48,72 hr | No |
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