Bioequivalence Study of Gabapentin 300 mg Capsule Manufactured by PT Bernofarm in Comparison with Gabapentin 300 mg Capsule, Neurontin® Manufactured by Pfizer Pharmaceuticals LLC., Puerto Rico; Packaged and released by Pfizer Manufacturing Deutschland GmbH, Germany; Imported by PT Pfizer Indonesia Under Fasting Condition

Tahapan Penelitian : Complete
Sponsor:
Mitra Pelaksana:
PT Biometrik Riset Indonesia
No Registry
INA-5WB0PMQM
Tanggal Input Registry : 22-09-2025

11-08-2025
AUC0-t , Cmax
AUC0-inf , Tmax, Half life
 
Bioequivalence Study of Gabapentin 300 mg Capsule Manufactured by PT Bernofarm in Comparison with Gabapentin 300 mg Capsule, Neurontin® Manufactured by Pfizer Pharmaceuticals LLC., Puerto Rico; Packaged and released by Pfizer Manufacturing Deutschland GmbH, Germany; Imported by PT Pfizer Indonesia Under Fasting Condition
Bioequivalence Study of Gabapentin 300 mg Capsule Manufactured by PT Bernofarm in Comparison with Gabapentin 300 mg Capsule, Neurontin® Manufactured by Pfizer Pharmaceuticals LLC., Puerto Rico; Packaged and released by Pfizer Manufacturing Deutschland GmbH, Germany; Imported by PT Pfizer Indonesia Under Fasting Condition
Interventional
Gabapentin 300 mg capsule, manufactured by PT Bernofarm
24
 

Inclusion Criteria:

a. Willing to participate and agree to sign informed consent and communicate well with the investigators. b. Healthy female/male subjects as determined by the medical screening assessments. c. Aged 18 - 55 years inclusive. d. Body mass index within the range of 18.00 - 25.00 kg/m2. e. Vital signs, after 10 minutes resting, within the following ranges: (i). Pulse rate: 60 - 90 bpm (based on ECG examination). (ii). Respiratory Rate: 12 - 20 x/minutes. (iii). Systolic blood pressure: 100 - 129 mmHg. (iv). Diastolic blood pressure: 60 - 84 mmHg. (v). Body temperature < 37.5°C. f. Have 12-lead ECG without significant abnormalities.

Exclusion Criteria:

a. Participate in another study within 3 (three) months prior to the first day of study drug administration. b. Pregnant or lactating female (urinary pregnancy test was performed on screening day and prior study drug administrations on each period). c. Smoker or smoking more than 10 (ten) cigarettes per day. d. Intake of any prescription drug or non-prescription drug within 7 days prior to the first day of drug administration of this study. e. Blood donation or blood loss of 300 mL (or more) within 3 (three) months prior to the first day of study drug administration. f. History of drug and/or alcohol abuse or dependency within 12 months prior to the first day of study drug administration. g. Known hypersensitivity or contraindication to the study drug or allied drug or other medicines, food/drinks, cold/hot weather, or other reasons. h. Any surgical or medical condition (present or history) which might significantly alter the absorption, distribution, metabolism or excretion of the study, e.g., gastrointestinal disease including gastric or duodenal ulcers or history of gastric surgery. i. Clinically significant hematology and urinalysis abnormalities. j. Renal insufficiency (plasma’s creatinine concentration ≥ 1.50 mg/dL). k. History or presence of any liver dysfunction (SGPT, SGOT, alkaline phosphate, total bilirubin ≥ 1.5 ULN). l. Positive result of HBsAg, HCV, and/or HIV test. m. Positive result of alcohol test and drug abuse such are opioids, amphetamines, benzodiazepines, and cannabis.
 
S-498/UN2.F1/ETIK/PPM.00.02/2025
Not applicable
PPUK/PPUB number
024/BE/APR-2025
Oktaviani Utami Dewi, S.Si - Ass. Manager QA Telp : 0853-2128-8082 e-Mail: oktaviani@biometrikriset.com