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
The clinical trial aims to assess the pharmacokinetics, safety and tolerability of HIP1502 in healthy male subjects.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RT | Experimental | period 1: HGP1604 1mg (reference drug, R) will be administered once orally. period 2: HIP1502 1mg (test drug, T) will be administered once orally after 14 days of the washout period. |
|
| TR | Experimental | period 1: HIP1502 1mg (test drug, T) will be administered once orally. period 2: HGP1604 1mg (reference drug, R) will be administered once orally after 14 days of the washout period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| varenicline tartrate 1mg (HGP1604, R) - varenicline oxalate 1mg (HIP1502, T), RT | Drug | varenicline tartrate 1mg (HGP1604) was used as a reference drug and varenicline oxalate 1mg (HIP1502) was used as a test drug. |
| Measure | Description | Time Frame |
|---|---|---|
| AUC | area under the plasma concentration-time curve | 0 (predose) ~ 96 hours |
| Cmax | maximum plasma concentration of the drug | 0 (predose) ~ 96 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Tmax | time to maximum plasma concentration | 0 (predose) ~ 96 hours |
| T1/2 | terminal elimination half-life | 0 (predose) ~ 96 hours |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept. of Clinical Pharmacology & Toxicology, Anam Hospital, Korea University College of Medicine | Seoul | 136-705 | South Korea |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
an open-label, randomized, single-dose crossover clinical trial
Not provided
Not provided
Not provided
Not provided
| varenicline oxalate 1mg (HIP1502, T) - varenicline tartrate 1mg (HGP1604, R), TR | Drug | varenicline tartrate 1mg (HGP1604) was used as a reference drug and varenicline oxalate 1mg (HIP1502) was used as a test drug. |
|
| CL/F | apparent total body clearance of the drug from plasma | 0 (predose) ~ 96 hours |
| Vd/F | apparent volume of distribution | 0 (predose) ~ 96 hours |
| ID | Term |
|---|---|
| D000068580 | Varenicline |
| ID | Term |
|---|---|
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D011810 | Quinoxalines |
Not provided
Not provided