Clinical trial NCT03712475: Pharmacokinetics of Two Formulation of Pregabalin
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetic Peripheral Neuropathy
Fibromyalgia
Partial Seizure Disorder
Keywords: Pharmacokinetic
Lead sponsor: Yung Shin Pharm. Ind. Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Taichung Veterans General Hospital
First posted: 2018-10-19
Enrollment: 28
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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.

Primary outcomes:
measure: Area under the plasma concentration (AUC)
timeFrame: Plasma sample: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 and 36 hours
measure: Peak Drug Concentration (Cmax)
timeFrame: Plasma sample: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 and 36 hours
measure: Elimination half-life (T1/2)
timeFrame: Time Frame: Plasma sample: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 and 36 hours
measure: Area under the (first) moment plasma concentration-time curve (AUMC)
timeFrame: Plasma sample: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 and 36 hours
Secondary outcomes:
measure: Adverse events
timeFrame: Within 8 weeks prior to the study, subjects were screened for their eligibility.
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
Study officials:
References: