Status:
COMPLETED
Bioequivalence Study of Two Formulations of Pregabalin Capsules 150 mg
Lead Sponsor:
Dexa Medica Group
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
NA
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 M...
Detailed Description
This was a randomized, open label, two-period, two-sequence, crossover study under fasting condition. The participating subjects were required to have an overnight fast and in the next morning were gi...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
June 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT02233777
Start Date
June 1 2014
End Date
June 1 2014
Last Update
September 8 2014
Active Locations (1)
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1
PT Equilab International
Jakarta, Jakarta Special Capital Region, Indonesia, 12430