Bioavailability/bioequivalence study of 150 mg Pregabalin Capsules: (Pregabalin 150 mg Kapsul) manufactured by PT Bernofarm in comparison with Pregabalin 150 mg, Lyrica® manufactured by Pfizer Manufacturing Deutschland GmbH, Freiburg Germany; imported by PT Pfizer, Indonesia.

Tahapan Penelitian : Complete
Sponsor:
Mitra Pelaksana:
PT Biometrik Riset Indonesia
No Registry
INA-R9L00H7
Tanggal Input Registry : 20-06-2023

13-01-2021
AUC0-t; Cmax
 
Bioavailability/bioequivalence study of 150 mg Pregabalin Capsules: (Pregabalin 150 mg Kapsul) manufactured by PT Bernofarm in comparison with Pregabalin 150 mg, Lyrica® manufactured by Pfizer Manufacturing Deutschland GmbH, Freiburg Germany; imported by PT Pfizer, Indonesia.
Bioavailability/bioequivalence study of 150 mg Pregabalin Capsules: (Pregabalin 150 mg Kapsul) manufactured by PT Bernofarm in comparison with Pregabalin 150 mg, Lyrica® manufactured by Pfizer Manufacturing Deutschland GmbH, Freiburg Germany; imported by PT Pfizer, Indonesia.
Interventional
The test drug was the market available Pregabalin 150 mg capsules manufactured by PT Bernofarm, Indonesia; batch number : RSK-19-034D; Manufacturing date : September 2019; Expired date : September 2021. The reference drug was the market available Pregabalin 150 mg capsules, Lyrica® manufactured by Pfizer Manufacturing Deutschland GmbH, Freiburg Germany; imported by PT Pfizer, Indonesia.; batch number : AK5479; Expired date : September 2021. In sampling day, Subjects took one dose of Pregabalin 150 mg capsules products of either formulation (Reference or Test) after an overnight fasted. As randomization scheme with 240 mL of water in sitting position. The subjects blood samples was taken at a certain times
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Inclusion Criteria:

a. Able to participate, agree to sign an 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). Systolic blood pressure: < 120 mmHg. (iii). Diastolic blood pressure: < 80 mmHg. f. Negative results of Covid-19 on stage 1 and 2 on IgM, IgG CoV-2 SARS testing, and thorax X-ray testing.

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 at screening day and prior to study drug administrations on each period). c. Smoking more than 10 (ten) cigarettes per day. d. Intake of any prescription drug or non-prescription drug within 7 days prior 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, alkaline phosphate, total bilirubin ≥ 1.5 ULN). n. Positive result of HBsAg, HCV, and/or HIV test.
 
 1213/UN2.F1/ETIK/2018 for Protocol version 1.00 (27/07/2018)  S-1621/UN2.F1/ETIK/PPM.00.02/2019 for Protocol version 1.01 (23/12/2019)  S-789/UN2.F1/ETIK/PPM.00.02/2020 for Protocol version 1.02 (20/07/2020)
Not applicable
PPUK/PPUB number
Oktaviani Utami Dewi, S.Si. - Ass.man QA