Clinical trial NCT03963362: The Pharmacokinetics of GLA5PR Tablet According to the Renal Function
Official title: Clinical Study to Evaluate Pharmacokinetics of GLA5PR Tablet According to the Renal Function
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Neuropathic Pain
Keywords: GLA5PR
Renal function
Pharmacokinetics
Pregabalin
Lead sponsor: GL Pharm Tech Corporation
Sponsor class: INDUSTRY
First posted: 2019-05-24
Enrollment: 24
Sex: ALL
Minimum age (years): 19
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evauate pharmacokinetics of GLA5PR tablet according to the renal function


Eligibility criteria: 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

Exclusion Criteria:

* Subject who is any history of gastrointestinal disease (e.g., Crohn's disease, and others), and surgery (except for simple appendectomy or repair of a hernia), which can influence the absorption of investigational products
* Subject who has a history of hypersensitivity or clinically significant hypersensitivity reactions to drugs or other drugs (aspirin, antibiotics, etc.) that contain components of the clinical trial drug or components of the same class (except for inactive allergic rhinitis)
* Subject who is genetic problem such as galactose intolerance, or Lapp lactose dehydrogenase deficiency, or glucose-galactose uptake disorder
* Subject with the exclusion criteria of 1 to 3, or a significant disease (epilepsy, etc.) and past disease that is considered difficult to participate in clinical trials according to the investigator's judgement
* Subject who had whole blood donation within 60 days or component blood donation within 30 days before the first administration of the investigational product, or transfusion within 60 days before the first administration
* Subject who has participated in any other clinical trials and had medication within 180 days prior to the first administration of investigational product
* Subject who has taken any ethical-the-counter drug or has taken any over-the-counter drug within 14 days before the screening visit, except to the taken the prior-medication for the disease treatment
* Subject who has taken any oriental medicines or any dietary supplements within 30 days, before the screening visit
* Subject who has taken any heavy drinking within 30 days before the screening visit (\>21 units/week)
* Subject who has taken a food expected to have an effect on the clinical trial within 7 days, before the screening visit; The food of contained in caffeine (\> 2 times/day) The products containing grapefruit (\> 2 times/day)
* Subject who has shown positive reaction to drugs that may be abused from a urine drug screening
* Subject who is positive result in smoking or urine nicotine test within 30 days, before the screening visit
* Subject who is positive result in serum test (hepatitis type B test, hepatitis type C test, Human Immunodeficiency Virus (HIV) test, and syphilis test), during the screening period
* Subject who showed the following findings in the tests conducted during the screening period;
* Less than the lower normal limit (LNL) in the Hb.
* In excess of 1.5 times the upper normal limit (UNL) in the hepatic enzyme (AST and ALT), and the alkaline phosphatase values
* In excess of 1.5 times the upper normal limit (UNL) in the total bilirubin
* Subject who is QTc \> 450 msec in ECG or a clinically significant abnormal rhythm during the screening period
* Subject who is not eligible person for the clinical trial according to the investigator's judgment

Primary outcomes:
measure: The Cmax of Pregabalin
timeFrame: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, and 72 hours after administration
measure: The AUClast of Pregabalin
timeFrame: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, and 72 hours after administration
Secondary outcomes:
measure: tmax of Pregabalin
timeFrame: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, 72 hours after administration
measure: t1/2beta of Pregabalin
timeFrame: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, and 72 hours after administration
measure: AUCinf of Pregabalin
timeFrame: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, and 72 hours after administration
measure: CL/F of Pregabalin
timeFrame: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, and 72 hours after administration
measure: Vz/F of Pregabalin
timeFrame: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, and 72 hours after administration
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
state: Songpa-gu
Study officials:
affiliation: GL PharmTech Corp.
name: Minchang Kwon, Ph. D
role: STUDY_DIRECTOR
References: