Neuropathic Pain
Conditions
Keywords
GLA5PR, Renal function, Pharmacokinetics, Pregabalin
Brief summary
To evauate pharmacokinetics of GLA5PR tablet according to the renal function
Interventions
DRUGGLA5PR tablet 75 mg
GLARS-NF3 tablet
DRUGGLA5PR tablet 150 mg
GLARS-NF3 tablet
Sponsors
GL Pharm Tech Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 64 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy subject who, at the time of screening, are the age between 19 and 64 years * Subject who has body weight more than 50 kg (45 kg in women), and less than 80 kg * Subject who normal renal function of the creatinine clearance calculated by Cockcroft-Gault equation over 90 mL/min * Subject who the mild renal function of the creatinine clearance between 60 and 89 mL/min calculated by Cockcroft-Gault equation * Subject who the moderate renal patient of the creatinine clearance between 30 and 59 mL/min calculated by Cockcroft-Gault equation * Subject who is clinically no significant by a medical history, physical, and psychological examination * Subject who clinically no significant a vital sign with Investigator's judgment * Subject who has result of diagnostic laboratory test excluding the items described in
Exclusion criteria
of the 13, and 14, and judged to be clinically no significant when medically by investigator * Subject who has consented to use a combination of effective contraceptive methods or medically appropriate contraceptive methods from the first administration of the clinical trial drug to the end of the clinical trial (when testing for final safety evaluation) and not to provide sperm or egg * Subject who is negative the serum and urine hCG test, and is not to pregnant and feeding * Subject who signed and dated the informed consent form after understanding fully to hear a detailed explanation in the clinical trial * Subject who is accept to the post-study visit and to be willing to providing of collection the blood, and urine
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Cmax of Pregabalin | Pre-dose, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, and 72 hours after administration | Cmax |
| The AUClast of Pregabalin | Pre-dose, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, and 72 hours after administration | AUClast |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AUCinf of Pregabalin | Pre-dose, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, and 72 hours after administration | AUCinf |
| tmax of Pregabalin | Pre-dose, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, 72 hours after administration | tmax |
| Vz/F of Pregabalin | Pre-dose, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, and 72 hours after administration | Vz/F |
| CL/F of Pregabalin | Pre-dose, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, and 72 hours after administration | CL/F |
| t1/2beta of Pregabalin | Pre-dose, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, and 72 hours after administration | t1/2beta |
Countries
South Korea
Contacts
Primary ContactJong Hyuk Jung, MS
Outcome results
None listed