Bioequivalence Study of Two Formulations of Pregabalin Capsules 150 mg

NCT02233777 | Completed

• 1 other identifier: BE.293/EQL/2013
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The present study was conducted to find out whether the bioavailability of 150 mg pregabalin capsules produced by Dexa Medica was equivalent to the reference products (Lyrica® capsule 150 mg, Pfizer Manufacturing Deutschland GmbH, Germany).

Conditions

Healthy

Keywords

Pregabalin; Bioequivalence; Bioavailability; Pharmacokinetic; Antiepileptic

Outcome Measures

Primary Outcomes (4)

• AUCt

  Area under plasma concentration time curve from time zero to the last observed quantifiable concentration was determined from plasma concentrations of pregabalin from the test drug and reference drug.

  36 hours

• AUCinf

  Area under plasma concentration time curve from time zero to infinity was determined from plasma concentrations of pregabalin from the test drug and reference drug.

  36 hours

• Cmax

  The peak plasma concentration of the drug was determined from plasma concentrations of pregabalin from the test drug and reference drug.

  36 hours

• Tmax

  The time needed to achieve the peak plasma concentration was determined from plasma concentrations of pregabalin from the test drug and reference drug.

  36 hours

Secondary Outcomes (1)

• T1/2

  36 hours

Study Arms (2)

Pregabalin capsules 150 mg of Dexa Medica

EXPERIMENTAL

Each capsule contains 150 mg pregabalin.

Drug: Pregabalin capsules 150 mg of Dexa Medica

Pregabalin capsules 150 mg of Pfizer Manufacturing Deutschland

ACTIVE COMPARATOR

Each capsule contains 150 mg pregabalin.

Drug: Pregabalin capsules 150 mg of Pfizer Manufacturing Deutschland

Interventions

Pregabalin capsules 150 mg of Dexa Medica DRUG

Each capsule contains 150 mg of pregabalin. Test product was given as a single dose, under the procedure as described in the Section: Detailed description of the study.

Also known as: Test product: pregabalin capsules 150 mg of Dexa Medica

Pregabalin capsules 150 mg of Dexa Medica

Pregabalin capsules 150 mg of Pfizer Manufacturing Deutschland DRUG

Each capsule contains 150 mg of pregabalin. Reference product was given as a single dose, under the procedure as described in the Section: Detailed description of the study.

Also known as: Reference product: Lyrica® 150 mg, produced by Pfizer Manufacturing Deutschland GmbH, Germany

Pregabalin capsules 150 mg of Pfizer Manufacturing Deutschland

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male and female subjects with absence of significant disease or clinically significant abnormal laboratory values or laboratory evaluation, medical history, or physical examination during the screening and could be considered healthy based on the evaluation
• Aged 18-55 years inclusive
• Preferably non-smokers or smoke less than 10 cigarettes per day
• Able to participate, communicate well with the investigators and willing to provide written informed consent to participate in the study
• Body mass index within 18 to 25 kg/m2
• Vital signs (after 10 minutes rest) within the following ranges:
• Systolic blood pressure: 100-120 mmHg
• Diastolic blood pressure: 60-80 mmHg
• Pulse rate: 60-90 bpm

You may not qualify if:

• Personal/family history of allergy or hypersensitivity or contraindication to pregabalin or allied drugs
• Pregnant or lactating women (urinary pregnancy test was applied to women subjects at screening and before taking the study drug)
• Any major illnesses in the past 90 days or clinically significant ongoing chronic medical illness e.g. congestive cardiac failure (heart failure), hepatitis, hypotensive episodes, hyperglycemia, etc
• Presence of any clinically significant abnormal values during screening, e.g. significant abnormality of liver function test (ALT, alkaline phosphatase, total bilirubin \>= 1.5 ULN), renal function test (serum creatinine concentration \> 1.4 mg/dL), etc
• Positive hepatitis B surface antigen (HBsAg), anti-HCV, or anti-HIV
• Clinically significant electrocardiogram (ECG) abnormalities
• Any surgical or medical condition (present or history) which might significantly alter the absorption, distribution, metabolism, or excretion of the study drug, e.g. gastrointestinal disease including gastric or duodenal ulcers or history of gastric surgery
• Past history of anaphylaxis or angiodema
• History of drug or alcohol abuse within 12 months prior to screening for this study
• Participation in any clinical trial within the past 90 days calculated from the last visit
• History of any bleeding or coagulative disorders
• History of seizure, epilepsy, or any kind of neurological disorders
• History of difficulty with donating blood or difficulty in accessibility of veins in left or right arm
• A donation or loss of 300 mL (or more) of blood within 3 months before this study's first dosing day
• Intake of any prescription, non-prescription drug, food supplements, or herbal medicines within 14 days of this study's first dosing day

Sponsors & Collaborators

• Dexa Medica Group: lead

Study Sites (1)

PT Equilab International

Jakarta, Jakarta Special Capital Region, 12430, Indonesia

Location

MeSH Terms

Interventions

Pregabalin

Intervention Hierarchy (Ancestors)

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

Study Officials

• Ratih SI Putri, MD

  PT Equilab International

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2014
• First Posted: September 8, 2014
• Study Start: June 1, 2014
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: September 8, 2014

Record last verified: 2014-09

Locations

ID (1)