Healthy
Conditions
Keywords
Tamsulosin,controlled release formulation
Brief summary
Study to Investigate The Pharmacokinetics of GL2702 GLARS-NF1 and Omix Ocas® in Healthy Male Volunteers
Detailed description
GL2702 GLARS-NF1 tablet is controlled released formulation which is invented by GL Pharm Tech Corp.
Interventions
DRUGGL2702 GLARS-NF1
0.4mg once a day
DRUGOmix Ocas
0.4mg once a day
Sponsors
GL Pharm Tech Corporation
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
20 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* 20\ 45 years old, Healthy Adult Male Subject * Body Weight ≥ 50kg and Ideal Body Weight ≤ ±20%
Exclusion criteria
* ALT or AST \> 1.25 times (Upper Normal Range) * Total Bilirubin \> 1.5 times (Upper Normal Range) * CPK \> 2 times (Upper Normal Range) * BUN or Creatinine \> Normal Range * Systolic BP \> 160mmHg or \< 80mmHg, Diastolic BP \> 100mmHg or \< 50mmHg
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cmax | 48 hours | Pharmacokinetic parameter of tamsulosin 0.4mg |
| AUClast | 48 hours | Pharmacokinetic parameter of Tamsulosin 0.4mg |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tmax | 48 hours | Pharmacokinetic parameter of Tamsulosin 0.4 mg |
| t1/2 | 48 hours | Pharmacokinetic parameter of Tamsulosin 0.4 mg |
| Vz/F | 48 hours | Pharmacokinetic parameter of Tamsulosin 0.4 mg |
| CL/F | 48 hours | Pharmacokinetic parameter of Tamsulosin 0.4 mg |
Countries
South Korea
Outcome results
None listed