Bioequivalence Study of 300 mg Gabapentin Capsules, Manufactured by PT Mudita Karuna for PT Pharma Laboratories (Pharmaneuro®) in Comparison with the Innovator's Capsules (Neurontin®), Manufactured by Pfizer Pharmaceuticals LLC, Vega Baja, Puerto Rico, Packed and Released by Pfizer manufacturing Deutschland GmbH, Betriebsstatte Freiburg, Germany, Imported by PT Pfizer Indonesia, Jakarta-Indonesia

Tahapan Penelitian : Complete
Sponsor:
Mitra Pelaksana:
Econolab
No Registry
INA-ADD0Q0F
Tanggal Input Registry : 27-05-2024

25-09-2020
AUC0-t, Cmax
AUC0-inf, Tmax, T1/2
 
Bioequivalence Study of 300 mg Gabapentin Capsules, Manufactured by PT Mudita Karuna for PT Pharma Laboratories (Pharmaneuro®) in Comparison with the Innovator's Capsules (Neurontin®), Manufactured by Pfizer Pharmaceuticals LLC, Vega Baja, Puerto Rico, Packed and Released by Pfizer manufacturing Deutschland GmbH, Betriebsstatte Freiburg, Germany, Imported by PT Pfizer Indonesia, Jakarta-Indonesia
Bioequivalence Study of 300 mg Gabapentin Capsules, Manufactured by PT Mudita Karuna for PT Pharma Laboratories (Pharmaneuro®) in Comparison with the Innovator's Capsules (Neurontin®), Manufactured by Pfizer Pharmaceuticals LLC, Vega Baja, Puerto Rico, Packed and Released by Pfizer manufacturing Deutschland GmbH, Betriebsstatte Freiburg, Germany, Imported by PT Pfizer Indonesia, Jakarta-Indonesia
Interventional
Single dose of 300 mg Gabapentin Capsules (Pharmaneuro®), Manufactured by PT Mudita Karuna for PT Pharma Laboratories
18
 

Inclusion Criteria:

Able to participate, communicate well with the investigators and agree to sign an informed consent; Willing to use contraception (condoms) when having intercourse with their partner during the study period; Healthy male/female subjects as determined by the medical screening assessments; Aged 18-55 years; Body mass index (BMI) is in the range of 18-25 kg/m²; Normal blood pressure (systolic 100-120 mmHg; diastolic 60-80 mmHg); Normal pulse rate (60-90 bpm); Normal electrocardiogram (ECG); Clinical laboratory results must be within normal range. Medical judgement of the responsible physician justified any laboratory finding beyond its standard value.

Exclusion Criteria:

Pregnant or lactating women (urinary pregnancy test were applied to female subjects when screening and just before taking the test or reference drug); Known hypersensitivity or contraindication to the study drug; Intake of any prescription drug or non-prescription drug/food supplement/herbal medicine within seven (7) days of this study’s first dosing day; History of any bleeding, or coagulation disorders; Any surgical or medical condition (present or history) which might significantly alters the absorption, distribution, metabolism or excretion of the study drug, e.g. gastrointestinal diseases including gastric or duodenal ulcers or history of gastric surgery; A donation or loss of 300 mL (or more) of blood within three (3) months before this study’s first dosing day; A positive Hepatitis B surface antigen (HBsAg), HCV, HIV test result; History of drug or alcohol abuse within twelve (12) months prior to the study; Heavy smoker (more than 10 cigarettes a day); Had clinically significant bleeding within three (3) months prior to the study; Participation in a previous study within three (3) months of this study’s first dosing day; A positive antibody against SARS-CoV-2 test result in the first phase (Phase I); A reactive SARS-CoV-2 antigen test result in the second phase (Phase II).
 
KET-327/UN2.F1/ETIK/PPM.00.02/2020
Not applicable
PPUK/PPUB number
PRO-249/20/ECL
Ni Made Dwi Wulandari