Bioequivalence study of multisource of gabapentin 300 mg capsule produced by PT Dexa Medica in comparison with the comparator drug (Neurontin® 300 mg Capsule produced by Pfizer Pharmaceutical LLC, Puerto Rico, packaged and released by Pfizer Manufacturing Deutschland GmbH, Germany, imported by PT Pfizer Indonesia, Indonesia) when administered under fasting condition in healthy subjects.

Tahapan Penelitian : Complete
Sponsor:
Mitra Pelaksana:
PT Equilab International
No Registry
INA-DQXZTQD
Tanggal Input Registry : 02-04-2024

11-12-2023
to find out whether the bioavailability of PT Dexa Medica’s formulation of gabapentin 300 mg capsule was equivalent to that of the comparator drug (Neurontin® 300 mg Capsule produced by Pfizer harmaceutical LLC, Puerto Rico, packaged and released by Pfizer Manufacturing Deutschland GmbH, Germany, imported by PT Pfizer
 
Bioequivalence study of multisource of gabapentin 300 mg capsule produced by PT Dexa Medica in comparison with the comparator drug (Neurontin® 300 mg Capsule produced by Pfizer Pharmaceutical LLC, Puerto Rico, packaged and released by Pfizer Manufacturing Deutschland GmbH, Germany, imported by PT Pfizer Indonesia, Indonesia) when administered under fasting condition in healthy subjects.
Bioequivalence study of multisource of gabapentin 300 mg capsule produced by PT Dexa Medica in comparison with the comparator drug (Neurontin® 300 mg Capsule produced by Pfizer Pharmaceutical LLC, Puerto Rico, packaged and released by Pfizer Manufacturing Deutschland GmbH, Germany, imported by PT Pfizer Indonesia, Indonesia) when administered under fasting condition in healthy subjects.
Interventional
Test drug: multisource of gabapentin 300 mg capsule (produced by PT Dexa Medica) Reference drug: Neurontin® 300 mg Capsule (produced by Pfizer Pharmaceutical LLC, Puerto Rico, packaged and released by Pfizer Manufacturing Deutschland GmbH, Germany, imported by PT Pfizer Indonesia, Indonesia)
30
 

Inclusion Criteria:

1.Able to participate, communicate well with the investigators and willing to provide written informed consent to participate in the study. 2. Healthy male and female subjects with absence of significant disease or clinically significant abnormal laboratory values on laboratory evaluation, medical history or physical examination during the screening and could be considered healthy based on the evaluation. 3. Aged 18 - 55 years inclusive. 4. Preferably non-smokers or smoke less than 10 cigarettes per day. 5. Body mass index within 18 to 25 kg/m2. 6. Vital signs (after 10 minutes rest) must be within the following ranges. - Systolic blood pressure : 100 - 129 mmHg - Diastolic blood pressure : 60 - 84 mmHg - Pulse rate : 60 - 90 bpm 7. Willing to practice abstention or use non-hormonal contraception during the study.

Exclusion Criteria:

1. History of allergy or hypersensitivity or contraindication to gabapentin or allied drug. 2. Pregnant or lactating female (urinary pregnancy test will be applied to female subjects at screening and before taking the study drug). 3. Any major illness in the past 90 days or clinically significant ongoing chronic medical illness. 4. Presence of any clinically significant abnormal values during screening e.g. significant abnormality of liver function test (AST, ALT, alkaline phosphatase, total bilirubin, direct bilirubin ≥ 1.5 ULN), renal function test (serum creatinine concentration > 1.4 mg/dL and ureum ≥ 1.5 ULN), etc. 5. Positive Hepatitis B surface antigen (HBsAg), anti-HCV, or anti-HIV. 6. Clinically significant hematology abnormalities. 7. Clinically significant electrocardiogram (ECG) abnormalities. 8. 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. 9. Past history of anaphylaxis or angioedema. 10. History of seizure, epilepsy or any kind of neurological disorders. 11. History of drug or alcohol abuse within 12 months prior to screening for this study. 12. Participation in any clinical trial within the past 90 days calculated from the last visit until this study’s first dosing day. 13. History of any bleeding or coagulative disorders. 14. Presence of difficulty in accessibility of veins in left or right arm during screening. 15. A donation or significant blood loss within 90 days before this study’s first dosing day. 16. Intake of any prescription (especially gabapentin), non-prescription drug (including hormonal contraception), food supplements or herbal medicines within 21 days of this study’s first dosing day.
 
KET-1329/UN2.F1/ETIK/PPM.00.02/2023, Amandemen S-776/UN2.F1/ETIK/PPM.00.02/2023
Not applicable
PPUK/PPUB number
Kartika Widyanty