Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Pharmacokinetics of GLA5PR Tablet According to the Renal Function

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03963362
Recruitment Status : Not yet recruiting
First Posted : May 24, 2019
Last Update Posted : May 24, 2019
Sponsor:
Information provided by (Responsible Party):
GL Pharm Tech Corporation

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

Condition or disease Intervention/treatment Phase
Neuropathic Pain Drug: GLA5PR tablet 75 mg Drug: GLA5PR tablet 150 mg Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Study to Evaluate Pharmacokinetics of GLA5PR Tablet According to the Renal Function
Estimated Study Start Date : June 23, 2019
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Tests

Arm Intervention/treatment
Experimental: Administration of GLA5PR 75 mg as 60~89 mL/min
Administration of GLA5PR 75 mg as 60~89 mL/min(CLcr)
Drug: GLA5PR tablet 75 mg
GLARS-NF3 tablet

Experimental: Administration of GLA5PR 75 mg over 90 mL/min
Administration of GLA5PR 75 mg over 90 mL/min(CLcr)
Drug: GLA5PR tablet 75 mg
GLARS-NF3 tablet

Experimental: Administration of GLA5PR 150 mg as 60~89 mL/min
Administration of GLA5PR 150 mg as 60~89 mL/min(CLcr)
Drug: GLA5PR tablet 150 mg
GLARS-NF3 tablet

Experimental: Administration of GLA5PR 150 mg over 90 mL/min
Administration of GLA5PR 150 mg over 90 mL/min(CLcr)
Drug: GLA5PR tablet 150 mg
GLARS-NF3 tablet

Experimental: Administration of GLA5PR 75 mg as 30~59 mL/min
Administration of GLA5PR 75 mg as 30~59 mL/min(CLcr)
Drug: GLA5PR tablet 75 mg
GLARS-NF3 tablet




Primary Outcome Measures :
  1. The Cmax of Pregabalin [ Time Frame: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, and 72 hours after administration ]
    Cmax

  2. The AUClast of Pregabalin [ Time Frame: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, and 72 hours after administration ]
    AUClast


Secondary Outcome Measures :
  1. tmax of Pregabalin [ Time Frame: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, 72 hours after administration ]
    tmax

  2. t1/2beta of Pregabalin [ Time Frame: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, and 72 hours after administration ]
    t1/2beta

  3. AUCinf of Pregabalin [ Time Frame: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, and 72 hours after administration ]
    AUCinf

  4. CL/F of Pregabalin [ Time Frame: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, and 72 hours after administration ]
    CL/F

  5. Vz/F of Pregabalin [ Time Frame: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, and 72 hours after administration ]
    Vz/F



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   19 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03963362


Contacts
Layout table for location contacts
Contact: Jong Hyuk Jung, MS 82-31-739-5220 ext 404 jhjung@glpt.co.kr

Sponsors and Collaborators
GL Pharm Tech Corporation
Investigators
Layout table for investigator information
Principal Investigator: Hyeong-Seok Lim, MD, Ph D. Asan Medical Center

Layout table for additonal information
Responsible Party: GL Pharm Tech Corporation
ClinicalTrials.gov Identifier: NCT03963362     History of Changes
Other Study ID Numbers: GLA5PR-107
First Posted: May 24, 2019    Key Record Dates
Last Update Posted: May 24, 2019
Last Verified: May 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by GL Pharm Tech Corporation:
GLA5PR
Renal function
Pharmacokinetics
Pregabalin
Additional relevant MeSH terms:
Layout table for MeSH terms
Neuralgia
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms