Healthy Clinical Trial
Official title:
Bioequivalence Study of 150 mg Pregabalin Capsules Produced by PT Dexa Medica in Comparison With the Comparator Product (Lyrica® Capsule 150 mg, Pfizer Manufacturing Deutschland GmbH, Germany)
Verified date | September 2014 |
Source | Dexa Medica Group |
Contact | n/a |
Is FDA regulated | No |
Health authority | Indonesia: National Agency of Drug and Food Control |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 20 |
Est. completion date | June 2014 |
Est. primary completion date | June 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 55 Years |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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 |
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Indonesia | PT Equilab International | Jakarta |
Lead Sponsor | Collaborator |
---|---|
Dexa Medica Group |
Indonesia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Primary | 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 | No |
Primary | Cmax | The peak plasma concentration of the drug was determined from plasma concentrations of pregabalin from the test drug and reference drug. | 36 hours | No |
Primary | 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 | No |
Secondary | T1/2 | The elimination half life was determined from plasma concentrations of pregabalin from the test drug and reference drug. | 36 hours | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06052553 -
A Study of TopSpin360 Training Device
|
N/A | |
Completed |
NCT05511077 -
Biomarkers of Oat Product Intake: The BiOAT Marker Study
|
N/A | |
Recruiting |
NCT04632485 -
Early Detection of Vascular Dysfunction Using Biomarkers From Lagrangian Carotid Strain Imaging
|
||
Completed |
NCT05931237 -
Cranberry Flavan-3-ols Consumption and Gut Microbiota in Healthy Adults
|
N/A | |
Terminated |
NCT04556032 -
Effects of Ergothioneine on Cognition, Mood, and Sleep in Healthy Adult Men and Women
|
N/A | |
Completed |
NCT04527718 -
Study of the Safety, Tolerability and Pharmacokinetics of 611 in Adult Healthy Volunteers
|
Phase 1 | |
Completed |
NCT04998695 -
Health Effects of Consuming Olive Pomace Oil
|
N/A | |
Completed |
NCT04065295 -
A Study to Test How Well Healthy Men Tolerate Different Doses of BI 1356225
|
Phase 1 | |
Completed |
NCT04107441 -
AX-8 Drug Safety, Tolerability and Plasma Levels in Healthy Subjects
|
Phase 1 | |
Completed |
NCT01442831 -
Evaluate the Absorption, Metabolism, And Excretion Of Orally Administered [14C] TR 701 In Healthy Adult Male Subjects
|
Phase 1 | |
Terminated |
NCT05934942 -
A Study in Healthy Women to Test Whether BI 1358894 Influences the Amount of a Contraceptive in the Blood
|
Phase 1 | |
Recruiting |
NCT05525845 -
Studying the Hedonic and Homeostatic Regulation of Food Intake Using Functional MRI
|
N/A | |
Completed |
NCT05515328 -
A Study in Healthy Men to Test How BI 685509 is Processed in the Body
|
Phase 1 | |
Completed |
NCT04967157 -
Cognitive Effects of Citicoline on Attention in Healthy Men and Women
|
N/A | |
Completed |
NCT05030857 -
Drug-drug Interaction and Food-effect Study With GLPG4716 and Midazolam in Healthy Subjects
|
Phase 1 | |
Recruiting |
NCT04494269 -
A Study to Evaluate Pharmacokinetics and Safety of Tegoprazan in Subjects With Hepatic Impairment and Healthy Controls
|
Phase 1 | |
Recruiting |
NCT04714294 -
Evaluate the Safety, Tolerability and Pharmacokinetics Characteristics of HPP737 in Healthy Volunteers
|
Phase 1 | |
Completed |
NCT04539756 -
Writing Activities and Emotions
|
N/A | |
Recruiting |
NCT04098510 -
Concentration of MitoQ in Human Skeletal Muscle
|
N/A | |
Completed |
NCT03308110 -
Bioavailability and Food Effect Study of Two Formulations of PF-06650833
|
Phase 1 |