Pharmacokinetics of Two Formulation of Pregabalin

Last updated: January 24, 2019
Sponsor: Yung Shin Pharm. Ind. Co., Ltd.
Overall Status: Completed

Phase

4

Condition

Fibromyalgia

Diabetic Neuropathy

Epilepsy

Treatment

N/A

Clinical Study ID

NCT03712475
YSP-RJH3001-01
  • Ages 20-45
  • Male
  • Accepts Healthy Volunteers

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Healthy adult male subjects between 20-45 years of age.

  2. Body weight within 80-120% of ideal body weight.

  • Ideal body weight (kg) = [height (cm) - 80] *0.7 for male subjects
  1. Acceptable medical history and physical examination including:
  • no particular clinically significant abnormalities in chest x-ray andelectrocardiogram results within six months prior to study drug dosing.

  • no particular clinical significance in general disease history within two monthsprior to study drug dosing.

  1. Acceptable biochemistry determinations (within normal limits or considered by theinvestigator or physician to be of no clinical significance) within two months priorto 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 andtriglyceride (TG).

  2. Acceptable hematology (within normal limits or considered by the investigator orphysician to be of no clinical significance) within two months prior to study drugdosing, which includes hemoglobin, hematocrit, red blood cell count, white blood cellcount with differentials and platelets.

  3. Acceptable urinalysis (within normal limits or considered by the investigator orphysician to be of no clinical significance) within two months prior to study drugdosing, which includes power of hydrogen (pH), blood, glucose, ketones, bilirubin andprotein.

  4. Male subjects willing to use a condom during any sexual contact with females ofreproductive potential for up to 10 weeks after study drug dosing.

  5. Have signed the written informed consent to participate in the study.

Exclusion

Exclusion Criteria:

  1. 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).

  2. A clinically significant illness or surgery within four weeks prior to study drugdosing (as determined by the investigator).

  3. History of gastrointestinal obstruction, inflammatory bowel disease, gallbladderdisease, pancreas disorder over last two years or history of gastrointestinal tractsurgery over last five years.

  4. History of kidney disease or urination problem over last two years deemed by theinvestigator to be clinically significant.

  5. Known or suspected history of drug abuse within lifetime as judged by theinvestigator.

  6. History of alcohol addiction or abuse within last five years as judged by theinvestigator.

  7. History of allergic response(s) to pregabalin or any other related drugs.

  8. Evidence of chronic or acute infectious diseases.

  9. Positive results for serum hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCVAb), or human immunodeficiency virus (HIV).

  10. Taking any drug known to induce or inhibit hepatic drug metabolism within four weeksprior to study drug dosing. Examples of inducers include: piperidines, carbamazepine,dexamethasone and rifampin. Examples of inhibitors include: cimetidine,diphenhydramine, fluvastatin, methadone and ranitidine.

  11. Taking any prescription medications within four weeks or any nonprescriptionmedications (excluding flu vaccination) within two weeks prior to study drug dosing.

  12. Use of any investigational drug within four weeks prior to study drug dosing.

  13. Donating more than 250 mL of blood within two months prior to study drug dosing ordonating plasma (e.g. plasmapheresis) within two weeks prior to study drug dosing.

  14. Any other medical reason as determined by the investigator.

Study Design

Total Participants: 28
Study Start date:
January 19, 2018
Estimated Completion Date:
December 03, 2018

Connect with a study center

  • Taichung Veterans General Hospital

    Taichung,
    Taiwan

    Site Not Available

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