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
| 1. Background | |
|---|---|
| Registration Number | INA-40N1FCP |
| Date of registry approval | 18-11-2024 |
| Registration Date | 12-11-2024 |
| Secondary identifiers | Yes |
| Name of issuing authority (for example protocol number, other registries, etc) | PT. Biometrik Riset Indonesia |
| Secondary identifier number | Not specified |
| Scientific study title | 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 |
| Public (popular study title) | 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 |
| 2. Sponsor and Funding | |
| Primary Sponsor | PT. Tempo Scan Pacific Tbk. |
| Source(s) of monetary or material support | PT. Tempo Scan Pacific Tbk. |
| Other partners | Not Specified |
| 3. Contact details | |
| Principal Investigator | |
| Principal investigator | apt. Dra. Effi Setiawati, M.M., M.Biomed |
| City | Depok, Jawa Barat 16416 |
| Country | Indonesia |
| Principal investigator's affiliation | PT Biometrik Riset Indonesia |
| Principal Investigator's email address | effi@biometrikriset.com |
| Public Queries | |
| Contact person name for public queries | Oktaviani Utami Dewi, S.Si |
| Address for public queries | Ruko Brickhouse Jl Raya Bogor Km 31, No.52 Unit H dan I, Kelurahan Cisalak, Kecamatan Sukmajaya |
| City | Depok, Jawa Barat |
| Country | Indonesia |
| ZIP | 16416 |
| Affiliation for public queries | PT Biometrik Riset Indonesia |
| Email address for public queries | oktaviani@biometrikriset.com |
| Phone number for public queries | 085321288082 |
| Scientific Queries | |
| Name of Contact for scientific queries | Oktaviani Utami Dewi, S.Si |
| Address for scientific queries | Ruko Brickhouse Jl Raya Bogor Km 31, No.52 Unit H dan I, Kelurahan Cisalak, Kecamatan Sukmajaya |
| City | Depok, Jawa Barat |
| Country | Indonesia |
| ZIP | 16416 |
| Affiliation of scientific queries contact | PT Biometrik Riset Indonesia |
| Email address for scientific queries | oktaviani@biometrikriset.com |
| 4. IRB & Regulatory | |
| Ethical Approval number | KET-746/UN2.F1/ETIK/PPM.00.02/2024 |
| Name of Ethics committee | Komite Etik Penelitian Kesehatan Fakultas Kedokteran Universitas Indonesia RSUP Nasional Dr. Cipto Mangunkusumo |
| Date of Ethic approval | 24-05-2024 |
| Contact details of Ethic Committee (phone, email, and office) | Komite Etik FKUI/RSCM Jl. Salemba 6, Jakarta Pusat Whatsapp : 0856-8701-608 Telp. 021 315 7008 E-mail :ec_fkui@yahoo.com |
| Number of Persetujuan Pelaksanaan Uji Klinik (PPUK)/Persetujuan Protokol Uji BE (PPUB) | RG.01.02.321.06.24.02705/UB |
| 5. Status | |
| Countries of recruitment | Indonesia |
| Study sites in Indonesia | PT Biometrik Indonesia |
| Recruitment status | Complete |
| Date of first enrollment | 11-07-2024 |
| Targeted Sample size | 00024 - |
| Number of enrolled participants | 24 |
| Date of study completion (last participant, last visit) | 24-07-2024 |
| 6. Study Design & Purpose | |
| Primary health condition(s) or problem(s) studied (e.g., depression, breast cancer,medication error) | Study in healthy human volunteers |
| Purpose of the study | Bioequivalence study |
| Study type | Interventional |
| Interventional Study category | Bioequivalence study |
| Method of allocation | |
| Description of the allocation concealment mechanism and sequence generation | |
| Masking | |
| Study intervention (study arm) | Gabapentin 300 mg capsules |
| Control intervention (control arm) | Neurontin® 300 mg Capsules |
| Intervention assignment | Crossover |
| 7. Eligibility Criteria | |
| Gender inclusion criteria | Male, Female |
| Minimum age | 18 years old |
| Maximum age | 55 years old |
| 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 |
| 8. Study Outcome | |
| Primary Outcome | |
| Name of primary outcome | AUC0-t, Cmax |
| Metric/method of measurement | Statistical analysis with Anova using Phoenix WinNonlin Version 8.4 (Certara L.P., St. Louis, MO, USA) |
| Timepoint(s) of measurement | Predose, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 15, and 24 hours |
| Secondary outcome 1 | |
| Name of secondary outcome 1 (SO1) | Yes, AUC0-inf, Tmax, T1/2 |
| Metric/method of measurement (SO1) | Statistical analysis with Anova using Phoenix WinNonlin Version 8.4 (Certara L.P., St. Louis, MO, USA) |
| Timepoint(s) of measurement (SO1) | Predose, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 15, and 24 hours |
| 9. Study Results | |
| Brief summary of study results | Since the 90% Confidence Interval (CI) with α = 5.00% for AUC0-24h and Cmax were within the range of 80.00-125.00% interval, it was concluded the test drug Gabapentin (BN: 120013) manufactured by PT Tempo Scan Pacific Tbk is BIOEQUIVALENCE in term of both rate and extent of absorption to the reference drug Neurontin® (BN: HE0977) 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 |
| Date of results summaries | 22-08-2024 |
| Participant flow | Not Specified |
| Baseline characteristic | |
| Adverse events | There are adverse events that occurred during this study, i.e. blood pressure higher than normal, blood pressure lower than normal, pulse higher than normal, and pulse lower than normal |
| Outcome measures | The bioequivalence rate extent of absorption was proven for both preparations by assessing geometric means and by statistic 90% Confidence Interval (CI) with α = 5.00% |
| 10. Publication | |
| URL hyperlink(s) related to results and publications | |
| IPD sharing statement (Statement regarding the intended sharing of deidentified individual clinical trial participant-level data (IPD)) | No |
| Plan for IPD sharing (what IPD will be shared, when, by what mechanism, with whom, and for what types of analyses) | |
| Other important informations | Not Specified |