Bioequivalence study of Gabapentin 300 mg capsule manufactured by PT. Ifars Pharmaceutical Laboratories (Galtenix 300 mg) in comparison with Neurontin® 300 mg capsule manufactured by Pfizer Pharmaceutical LLC, Vega Baja, Puerto Rico, packaged by Pfizer Manufacturing Deutschland GmbH Bettriebsstatte Freiburg, Germany, imported by PT. Pfizer Indonesia, Jakarta, Indonesia.

Tahapan Penelitian : Rampung
Sponsor:
Mitra Pelaksana:
PT. Pharma Metric Labs
No Registry
INA-W6F
Tanggal Input Registry : 29-09-2022

20-08-2021
To investigate whether Gabapentin 300 mg capsule manufactured by PT. Ifars Pharmaceutical Laboratories (Galtenix 300 mg) is bioequivalent to its reference product, Neurontin® 300 mg capsule manufactured by Pfizer Pharmaceutical LLC, Vega Baja, Puerto Rico, packaged by Pfizer Manufacturing Deutschland GmbH Bettriebsstatte Freiburg, Germany, imported by PT. Pfizer Indonesia, Jakarta, Indonesia.
N.A
 
Bioequivalence study of Gabapentin 300 mg capsule manufactured by PT. Ifars Pharmaceutical Laboratories (Galtenix 300 mg) in comparison with Neurontin® 300 mg capsule manufactured by Pfizer Pharmaceutical LLC, Vega Baja, Puerto Rico, packaged by Pfizer Manufacturing Deutschland GmbH Bettriebsstatte Freiburg, Germany, imported by PT. Pfizer Indonesia, Jakarta, Indonesia.
Bioequivalence study of Gabapentin 300 mg capsule manufactured by PT. Ifars Pharmaceutical Laboratories (Galtenix 300 mg) in comparison with Neurontin® 300 mg capsule manufactured by Pfizer Pharmaceutical LLC, Vega Baja, Puerto Rico, packaged by Pfizer Manufacturing Deutschland GmbH Bettriebsstatte Freiburg, Germany, imported by PT. Pfizer Indonesia, Jakarta, Indonesia.
Eksperimental
Subjects were given a single dose of 300 mg gabapentin of either formulation (test or reference) with 240 ml of water
23
 

Inclusion Criteria:

The inclusion criteria were healthy subjects who/with: - had read the subject information and signed informed consent documents - healthy male and female - age range from 18 – 55 years - body mass index between 18 – 25 kg/m2 - had a normal electrocardiogram - had the blood pressure within normal range (systolic 90 - 120 mmHg and diastolic 60 - 80 mmHg) - had the heart rate within normal range (60 – 100 bpm) - had absence of significant disease or clinically significant abnormal laboratory values on laboratory evaluation, medical history or physical examination during screening. - had agreed to use non-hormonal contraceptives methods (condom) before any intercourse with their spouse throughout the study

Exclusion Criteria:

This study was not eligible for: - those who were pregnant and/or nursing condition. - those with a history of contraindication or hypersensitivity to gabapentin, or other anti-convulsant or other ingredients in the drugs or a history of serious allergic reaction to any drug, a significant allergic disease, or allergic reaction. - those with a history or presence of medical condition which might significantly influence the pharmacokinetics of the study drug, e.g. chronic gastrointestinal disease, diarrhea, gastric surgery, renal insufficiency, hepatic dysfunction or cardiovascular disease. - those with a history or presence of any coagulation disorder or clinically significant hematology abnormalities. - those who were using any medication (prescription or non-prescription drug, food supplement, herbal medicine), particularly the medication known to affect the pharmacokinetic of the study drug, within one week prior to the drug administration day. - those who had participated in any clinical study within 3 months prior to the study (< 90 days). - those who had donated or lost 300 ml (or more) of blood within 3 months prior to the study. - those who smoked more than 10 cigarettes a day - those with a history of travelling to another city within the last 14 days - those with a history of direct contact with a COVID-19 positive person in the subject’s neighborhood - those with a history or present of sore throat, fever (with temperature more than 37°C) or dyspnea with in the last 14 days - those who were positive to SARS CoV-2 antigen test - those who were positive to HIV, HBsAg, and HCV tests (to be kept confidential). - those with a history of drug or alcohol abuse within 12 months prior to screening for this study. - those who were unlikely to comply with the protocol, e.g uncooperative attitude, inability to return for follow up visits, poor venous access.
 
No. KET-415A/UN2.F1/ETIK/PPM.00.02/2021
N.A
RG.01.02.321.07.21.00253/UB
445/STD/PML/2019
Nabila Mudin S