Pharmacokinetics of Two Formulation of Pregabalin

NCT03712475 | Completed Phase 4

• 1 other identifier: YSP-RJH3001-01
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

A Randomized, Single-Dose, Parallel-Group Study to Evaluate the Pharmacokinetic Profiles of Two Formulations of Pregabalin after Oral Administration in Healthy Volunteers under Fasting Conditions

Conditions

Diabetic Peripheral Neuropathy; Fibromyalgia; Partial Seizure Disorder

Keywords

Pharmacokinetic

Outcome Measures

Primary Outcomes (4)

• Area under the plasma concentration (AUC)

  Plasma sample: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 and 36 hours

• Peak Drug Concentration (Cmax)

  Plasma sample: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 and 36 hours

• Elimination half-life (T1/2)

  Time Frame: Plasma sample: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 and 36 hours

• Area under the (first) moment plasma concentration-time curve (AUMC)

  Plasma sample: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 and 36 hours

Secondary Outcomes (1)

• Adverse events

  Within 8 weeks prior to the study, subjects were screened for their eligibility.

Study Arms (2)

Phudialin Hard Capsules

EXPERIMENTAL

Phudialin Hard Capsules Dosing Regimen: Single dosing

Drug: Pregabalin

Lyrica Hard Capsule

ACTIVE COMPARATOR

Lyrica Hard Capsule Dosing Regimen: Single dosing

Drug: Pregabalin

Interventions

Pregabalin DRUG

pharmacokinetic study under fasting conditions

Lyrica Hard Capsule; Phudialin Hard Capsules

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adult male subjects between 20-45 years of age.
• Body weight within 80-120% of ideal body weight.
• \* Ideal body weight (kg) = \[height (cm) - 80\] \*0.7 for male subjects
• Acceptable medical history and physical examination including:
• no particular clinically significant abnormalities in chest x-ray and electrocardiogram results within six months prior to study drug dosing.
• no particular clinical significance in general disease history within two months prior to study drug dosing.
• Acceptable biochemistry determinations (within normal limits or considered by the investigator or physician to be of no clinical significance) within two months prior to study drug dosing, which includes Serum Glutamic Oxaloacetic Transaminase (SGOT, same as AST), Serum Glutamic Pyruvic Transaminase (SGPT, same as ALT), Gamma-Glutamyl-Transpeptidase (γ-GT), alkaline phosphatase, total bilirubin, albumin, glucose, Blood Urea Nitrogen(BUN), uric acid, creatinine, total cholesterol and triglyceride (TG).
• Acceptable hematology (within normal limits or considered by the investigator or physician to be of no clinical significance) within two months prior to study drug dosing, which includes hemoglobin, hematocrit, red blood cell count, white blood cell count with differentials and platelets.
• Acceptable urinalysis (within normal limits or considered by the investigator or physician to be of no clinical significance) within two months prior to study drug dosing, which includes power of hydrogen (pH), blood, glucose, ketones, bilirubin and protein.
• Male subjects willing to use a condom during any sexual contact with females of reproductive potential for up to 10 weeks after study drug dosing.
• Have signed the written informed consent to participate in the study.

You may not qualify if:

• A clinically significant disorder involving the cardiovascular, respiratory, hepatic, renal, gastrointestinal, immunologic, hematologic, endocrine or neurologic system(s) or psychiatric disease (as determined by the investigator).
• A clinically significant illness or surgery within four weeks prior to study drug dosing (as determined by the investigator).
• History of gastrointestinal obstruction, inflammatory bowel disease, gallbladder disease, pancreas disorder over last two years or history of gastrointestinal tract surgery over last five years.
• History of kidney disease or urination problem over last two years deemed by the investigator to be clinically significant.
• Known or suspected history of drug abuse within lifetime as judged by the investigator.
• History of alcohol addiction or abuse within last five years as judged by the investigator.
• History of allergic response(s) to pregabalin or any other related drugs.
• Evidence of chronic or acute infectious diseases.
• Positive results for serum hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCVAb), or human immunodeficiency virus (HIV).
• Taking any drug known to induce or inhibit hepatic drug metabolism within four weeks prior to study drug dosing. Examples of inducers include: piperidines, carbamazepine, dexamethasone and rifampin. Examples of inhibitors include: cimetidine, diphenhydramine, fluvastatin, methadone and ranitidine.
• Taking any prescription medications within four weeks or any nonprescription medications (excluding flu vaccination) within two weeks prior to study drug dosing.
• Use of any investigational drug within four weeks prior to study drug dosing.
• Donating more than 250 mL of blood within two months prior to study drug dosing or donating plasma (e.g. plasmapheresis) within two weeks prior to study drug dosing.
• Any other medical reason as determined by the investigator.

Sponsors & Collaborators

• Yung Shin Pharm. Ind. Co., Ltd.: lead
• Taichung Veterans General Hospital: collaborator

Study Sites (1)

Taichung Veterans General Hospital

Taichung, Taiwan

Location

MeSH Terms

Conditions

Fibromyalgia; Epilepsies, Partial

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Epilepsy; Brain Diseases; Central Nervous System Diseases

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2018
• First Posted: October 19, 2018
• Study Start: January 19, 2018
• Primary Completion: September 16, 2018
• Study Completion: December 3, 2018
• Last Updated: January 28, 2019

Record last verified: 2019-01

Locations

TW (1)