Bioequivalence Study of Pregabalin 150 mg Capsules Manufactured by PT Kimia Farma Tbk in Comparison with Lyrica®150 mg Capsules Manufactured by Pfizer Manufacturing Deutschland GmbH, Freiburg, Germany, imported by PT. Pfizer Indonesia, Jakarta.

Tahapan Penelitian : Complete
Sponsor:
Mitra Pelaksana:
PT Pharma Metric Labs
No Registry
INA-4GPX4FY
Tanggal Input Registry : 18-01-2024

19-03-2023
AUC0-t , Cmax
AUC0-inf , Tmax, Half life
 
Bioequivalence Study of Pregabalin 150 mg Capsules Manufactured by PT Kimia Farma Tbk in Comparison with Lyrica®150 mg Capsules Manufactured by Pfizer Manufacturing Deutschland GmbH, Freiburg, Germany, imported by PT. Pfizer Indonesia, Jakarta.
Bioequivalence Study of Pregabalin 150 mg Capsules Manufactured by PT Kimia Farma Tbk in Comparison with Lyrica®150 mg Capsules Manufactured by Pfizer Manufacturing Deutschland GmbH, Freiburg, Germany, imported by PT. Pfizer Indonesia, Jakarta.
Interventional
PREGABALIN 150 MG CAPSULES MANUFACTURED BY PT KIMIA FARMA TBK
20
 

Inclusion Criteria:

1.Have read the subject information and able to give written informed consent for participation in the study and comply with the study protocol/procedures 2.Healthy male and female 3.Age between 18 – 55 years 4.Body Mass Index (BMI) between 18–25 kg/m2 5.Having a normal electrocardiogram 6.resting vital signs (after 10 – 15 minutes of resting) are within the following ranges - Systolic blood pressure: 90 – 129 mmHg - Diastolic blood pressure: 60 – 84 mmHg - Pulse/Heart rate: 60 – 100 beats per minute (based on ESC Guideline for Hypertension (2018)) 7.Having no significant disease or clinically significant abnormal laboratory values on laboratory evaluation, medical history or physical examination during screening. 8.Accept to use contraception (condom) during intercourse with subjects’ spouse within study period.

Exclusion Criteria:

-Those who were Pregnant and/or nursing condition. -Those with a history of hypersensitivity or contraindication to pregabalin, or allied drugs, or other ingredients in the study products, 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/intestine surgery, renal insufficiency, hepatic dysfunction or cardiovascular disease. -Having history or presence of any coagulation disorder or clinically significant hematology abnormalities. -Those who using any medication (prescription or non-prescription drug, food supplement, herbal medicine), particularly the medication known to affect the pharmacokinetics of the study drug, within one week prior to the drug administration day. -Those who participated in any clinical study within the past 90 days prior to the study. - Those who having donate or lost 300 ml (or more) of blood within 3 months prior to the study. - Those who smoking habit with more than 10 cigarettes a day. -Those with history of travelling to another city within the last 14 days without following health authority regulation. -Those with history of direct contact with a COVID-19 positive person in the subject’s neighborhood within the last 5 days. -Those with history or present of sore throat, fever (with temperature more than 37°C) or dyspnea with in the last 14 days. -Those who positive result for SARS CoV-2 swab antigen test -Those who p ositive result for HIV, HbsAg, and HCV tests (to be kept confidential). -Those with history of drug or alcohol abuse within 12 months prior to screening for this study. -Those who was unlikely to comply with the protocol, e.g. uncooperative attitude, inability to return for follow up visits, poor venous access.
 
KET-93/UN2.F1/ETIK/PPM.00.02/2023
Not applicable
PPUK/PPUB number
Nabila Mudin Sutanto, Pharm