Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a single-blind, randomized, comparative, phase I study to evaluate the tolerability, safety and pharmacokinetic characteristics of human chorionic gonadotropin between two recombinant hCG products named DA-3803 injection and ovidrel liquid injection, in healthy subjects. The subjects will injected with these two injections at the the 21day-interval of time and their conditions including vital signs, blood, clinical examination will be carefully observed.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| T-R (Test-Reference drug) | Experimental | DA-3803 Injection is injected first and Ovidrel liquid injection is injected after 3-week period |
|
| R-T (Reference-Test drug) | Experimental | Ovidrel liquid injection is injected first and DA-3803 Injection is injected after 3-week period |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| T-R (Test-Reference drug) | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Concentration in serum of hCG examined by non-compartmental analysis | Examine the following:
| 3 weeks |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ji-Young Park, M.D., Ph.D. | Korea University Anam Hospital | Principal Investigator |
| Kyoung-Ah Kim, Ph.D. | Korea University Anam Hospital | Study Director |
| Un Jip Kim, M.D., Ph.D. | Korea University Anam Hospital | Study Director |
| Soo Kyung Kim, M.D., Ph.D. | Korea University Anam Hospital | Study Director |
| Hyun Tae Park, M.D., Ph.D. | Korea University Anam Hospital | Study Director |
Not provided
Not provided
| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D004341 | Drug Evaluation |
| ID | Term |
|---|---|
| D000076722 | Drug Development |
| D008919 | Investigative Techniques |
| D005069 | Evaluation Studies as Topic |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| R-T (Reference-Test drug) | Drug |
|
|