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Pharmacokinetics of Two Formulation of Pregabalin

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ClinicalTrials.gov Identifier: NCT03712475
Recruitment Status : Completed
First Posted : October 19, 2018
Last Update Posted : January 28, 2019
Sponsor:
Collaborator:
Taichung Veterans General Hospital
Information provided by (Responsible Party):
Yung Shin Pharm. Ind. Co., Ltd.

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

Condition or disease Intervention/treatment Phase
Diabetic Peripheral Neuropathy Fibromyalgia Partial Seizure Disorder Drug: Pregabalin Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Single-dose, Parallel-group Study to Evaluate the Pharmacokinetic Profiles of Two Formulation of Pregabalin in Healthy Volunteers Under Fasting Conditions
Actual Study Start Date : January 19, 2018
Actual Primary Completion Date : September 16, 2018
Actual Study Completion Date : December 3, 2018


Arm Intervention/treatment
Experimental: Phudialin Hard Capsules
Phudialin Hard Capsules Dosing Regimen: Single dosing
Drug: Pregabalin
pharmacokinetic study under fasting conditions

Active Comparator: Lyrica Hard Capsule
Lyrica Hard Capsule Dosing Regimen: Single dosing
Drug: Pregabalin
pharmacokinetic study under fasting conditions




Primary Outcome Measures :
  1. Area under the plasma concentration (AUC) [ Time Frame: Plasma sample: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 and 36 hours ]
  2. Peak Drug Concentration (Cmax) [ Time Frame: Plasma sample: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 and 36 hours ]
  3. Elimination half-life (T1/2) [ Time Frame: Time Frame: Plasma sample: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 and 36 hours ]
  4. Area under the (first) moment plasma concentration-time curve (AUMC) [ Time Frame: Plasma sample: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 and 36 hours ]

Secondary Outcome Measures :
  1. Adverse events [ Time Frame: Within 8 weeks prior to the study, subjects were screened for their eligibility. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

  3. 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.
  4. 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).
  5. 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.
  6. 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.
  7. 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.
  8. Have signed the written informed consent to participate in the study.

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 drug dosing (as determined by the investigator).
  3. 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.
  4. History of kidney disease or urination problem over last two years deemed by the investigator to be clinically significant.
  5. Known or suspected history of drug abuse within lifetime as judged by the investigator.
  6. History of alcohol addiction or abuse within last five years as judged by the investigator.
  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 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.
  11. Taking any prescription medications within four weeks or any nonprescription medications (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 or donating plasma (e.g. plasmapheresis) within two weeks prior to study drug dosing.
  14. Any other medical reason as determined by the investigator.

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): NCT03712475


Locations
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Taiwan
Taichung Veterans General Hospital
Taichung, Taiwan
Sponsors and Collaborators
Yung Shin Pharm. Ind. Co., Ltd.
Taichung Veterans General Hospital

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Responsible Party: Yung Shin Pharm. Ind. Co., Ltd.
ClinicalTrials.gov Identifier: NCT03712475     History of Changes
Other Study ID Numbers: YSP-RJH3001-01
First Posted: October 19, 2018    Key Record Dates
Last Update Posted: January 28, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Yung Shin Pharm. Ind. Co., Ltd.:
Pharmacokinetic

Additional relevant MeSH terms:
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Fibromyalgia
Seizures
Peripheral Nervous System Diseases
Diabetic Neuropathies
Epilepsy
Epilepsies, Partial
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Brain Diseases
Central Nervous System Diseases
Pregabalin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Anti-Anxiety Agents
Tranquilizing Agents