Bioequivalence study of Gabapentin 300 mg capsule manufactured by PT Tempo Scan Pacific Tbk in comparison with Gabapentin 300 mg capsule, Neurontin® manufactured by Pfizer Pharmaceuticals LLC, Vega Baja, Puerto Rico; Packed and released by Pfizer Manufacturing Deutschland GmbH, Betriebsstätte Freiburg, Germany; Imported by Pfizer, Jakarta, Indonesia

Tahapan Penelitian : Complete
Sponsor:
Mitra Pelaksana:
Not Specified
No Registry
INA-40N1FCP
Tanggal Input Registry : 12-11-2024

11-07-2024
AUC0-t, Cmax
Yes, AUC0-inf, Tmax, T1/2
 
Bioequivalence study of Gabapentin 300 mg capsule manufactured by PT Tempo Scan Pacific Tbk in comparison with Gabapentin 300 mg capsule, Neurontin® manufactured by Pfizer Pharmaceuticals LLC, Vega Baja, Puerto Rico; Packed and released by Pfizer Manufacturing Deutschland GmbH, Betriebsstätte Freiburg, Germany; Imported by Pfizer, Jakarta, Indonesia
Bioequivalence study of Gabapentin 300 mg capsule manufactured by PT Tempo Scan Pacific Tbk in comparison with Gabapentin 300 mg capsule, Neurontin® manufactured by Pfizer Pharmaceuticals LLC, Vega Baja, Puerto Rico; Packed and released by Pfizer Manufacturing Deutschland GmbH, Betriebsstätte Freiburg, Germany; Imported by Pfizer, Jakarta, Indonesia
Interventional
Gabapentin 300 mg capsules
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. (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. g. Do not have symptoms of Covid-19 and a history of close contact with Covid-19 patients h. Have received the primary SARS-CoV-2 vaccine complete and at least the first booster.

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 will be performed on screening day and prior study drug administrations on each period). c. Smoker 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. 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. History of any bleeding or coagulative disorders. j. Clinically significant hematology abnormalities. k. Clinically significant urinalysis abnormalities. l. Renal insufficiency (plasma’s creatinine concentration ≥ 1.50 mg/dL). m. History or presence of any liver dysfunction (SGPT, SGOT, alkaline phosphate, total bilirubin ≥ 1.5 ULN). n. Positive result of HBsAg, HCV, and/or HIV test
 
KET-746/UN2.F1/ETIK/PPM.00.02/2024
Not applicable
PPUK/PPUB number
Not specified
Oktaviani Utami Dewi, S.Si