The Pharmacokinetics of GLA5PR Tablet According to the Renal Function

NCT03963362 | Unknown Phase 1

• 1 other identifier: GLA5PR-107
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

To evauate pharmacokinetics of GLA5PR tablet according to the renal function

Conditions

Neuropathic Pain

Keywords

GLA5PR; Renal function; Pharmacokinetics; Pregabalin

Outcome Measures

Primary Outcomes (2)

• The Cmax of Pregabalin

  Cmax

  Pre-dose, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, and 72 hours after administration

• The AUClast of Pregabalin

  AUClast

  Pre-dose, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, and 72 hours after administration

Secondary Outcomes (5)

• tmax of Pregabalin

  Pre-dose, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, 72 hours after administration

• t1/2beta of Pregabalin

  Pre-dose, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, and 72 hours after administration

• AUCinf of Pregabalin

  Pre-dose, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, and 72 hours after administration

• CL/F of Pregabalin

  Pre-dose, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, and 72 hours after administration

• Vz/F of Pregabalin

  Pre-dose, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, and 72 hours after administration

Study Arms (5)

Administration of GLA5PR 75 mg as 60~89 mL/min

EXPERIMENTAL

Administration of GLA5PR 75 mg as 60\~89 mL/min(CLcr)

Drug: GLA5PR tablet 75 mg

Administration of GLA5PR 75 mg over 90 mL/min

EXPERIMENTAL

Administration of GLA5PR 75 mg over 90 mL/min(CLcr)

Drug: GLA5PR tablet 75 mg

Administration of GLA5PR 150 mg as 60~89 mL/min

EXPERIMENTAL

Administration of GLA5PR 150 mg as 60\~89 mL/min(CLcr)

Drug: GLA5PR tablet 150 mg

Administration of GLA5PR 150 mg over 90 mL/min

EXPERIMENTAL

Administration of GLA5PR 150 mg over 90 mL/min(CLcr)

Drug: GLA5PR tablet 150 mg

Administration of GLA5PR 75 mg as 30~59 mL/min

EXPERIMENTAL

Administration of GLA5PR 75 mg as 30\~59 mL/min(CLcr)

Drug: GLA5PR tablet 75 mg

Interventions

GLA5PR tablet 75 mg DRUG

GLARS-NF3 tablet

Administration of GLA5PR 75 mg as 30~59 mL/min; Administration of GLA5PR 75 mg as 60~89 mL/min; Administration of GLA5PR 75 mg over 90 mL/min

GLA5PR tablet 150 mg DRUG

GLARS-NF3 tablet

Administration of GLA5PR 150 mg as 60~89 mL/min; Administration of GLA5PR 150 mg over 90 mL/min

Eligibility Criteria

• Age: 19 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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 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

Sponsors & Collaborators

• GL Pharm Tech Corporation: lead

Study Sites (1)

Asan Medical Center

Seoul, Songpa-gu, 05505, South Korea

RECRUITING

MeSH Terms

Conditions

Neuralgia

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Minchang Kwon, Ph. D

  GL PharmTech Corp.

  STUDY DIRECTOR

Central Study Contacts

Jong Hyuk Jung, MS

CONTACT

82-31-739-5220; jhjung@glpt.co.kr

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2019
• First Posted: May 24, 2019
• Study Start: September 17, 2019
• Primary Completion: December 31, 2020
• Study Completion: June 30, 2021
• Last Updated: July 23, 2020

Record last verified: 2020-07

Locations

KR (1)