Bioequivalence Study of Sitagliptin Phosphate Monohydrate 100 mg Film-Coated Tablet Produced by PT Kimia Farma Tbk Compared to JanuviaTM 100 mg Film-Coated Tablet Produced by Organon Pharma (UK) Limited, Cramlington, England, Registered and Packed by PT. Organon Pharma Indonesia Tbk, Pasuruan Indonesia.
| 1. Background | |
|---|---|
| Registration Number | INA-65MY8QZE |
| Date of registry approval | 20-06-2025 |
| Registration Date | 18-06-2025 |
| Secondary identifiers | Yes |
| Name of issuing authority (for example protocol number, other registries, etc) | Not Specified |
| Secondary identifier number | NA |
| Scientific study title | Bioequivalence Study of Sitagliptin Phosphate Monohydrate 100 mg Film-Coated Tablet Produced by PT Kimia Farma Tbk Compared to JanuviaTM 100 mg Film-Coated Tablet Produced by Organon Pharma (UK) Limited, Cramlington, England, Registered and Packed by PT. Organon Pharma Indonesia Tbk, Pasuruan Indonesia. |
| Public (popular study title) | Bioequivalence Study of Sitagliptin Phosphate Monohydrate 100 mg Film-Coated Tablet Produced by PT Kimia Farma Tbk Compared to JanuviaTM 100 mg Film-Coated Tablet Produced by Organon Pharma (UK) Limited, Cramlington, England, Registered and Packed by PT. Organon Pharma Indonesia Tbk, Pasuruan Indonesia. |
| 2. Sponsor and Funding | |
| Primary Sponsor | PT Kimia Farma Tbk |
| Source(s) of monetary or material support | from the Sponsor, PT Kimia Farma Tbk |
| Other partners | EQuitrust Lab - PT Kimia Farma Diagnostika |
| 3. Contact details | |
| Principal Investigator | |
| Principal investigator | Dr. Lucy Sasongko, Pharm, MSi |
| City | Central Jakarta |
| Country | INDONESIA |
| Principal investigator's affiliation | Study Coordinator - Bayu Hadi Wahyono, Pharm, B.Pharm, MPH |
| Principal Investigator's email address | lab.equitrust@gmail.com |
| Public Queries | |
| Contact person name for public queries | Bayu Hadi Wahyono, Pharm, B.Pharm, MPH - Study Coordinator (+62 821 2559 0521 - lab.equitrust@gmail.com) |
| Address for public queries | PT. Kimia Farma Diagnostika EQuitrust Laboratory Jl. Bendungan Hilir Raya No. 60 Central Jakarta 10210 – INDONESIA |
| City | Central Jakarta |
| Country | INDONESIA |
| ZIP | 10210 |
| Affiliation for public queries | https://www.equitrustlab.com/ |
| Email address for public queries | lab.equitrust@gmail.com |
| Phone number for public queries | +62 821 2559 0521 |
| Scientific Queries | |
| Name of Contact for scientific queries | Bayu Hadi Wahyono, Pharm, B.Pharm, MPH |
| Address for scientific queries | PT. Kimia Farma Diagnostika EQuitrust Laboratory Jl. Bendungan Hilir Raya No. 60 Central Jakarta 10210 – INDONESIA |
| City | Central Jakarta |
| Country | INDONESIA |
| ZIP | 10210 |
| Affiliation of scientific queries contact | Study Coordinator - Bayu Hadi Wahyono, Pharm, B.Pharm, MPH |
| Email address for scientific queries | lab.equitrust@gmail.com |
| 4. IRB & Regulatory | |
| Ethical Approval number | KET-168/UN2.F1/ETIK/PPM.00.02/2025 |
| Name of Ethics committee | Komite Etik Penelitian Kesehatan, FK Universitas Indonesia - RSUPN Dr. Cipto Mangunkusumo |
| Date of Ethic approval | 14-04-2025 |
| Contact details of Ethic Committee (phone, email, and office) | Komite Etik FKUI/RSCM Jl. Salemba 6, Jakarta Pusat Telp. 021 315 7008 e-mail: ec_fkui@yahoo.com |
| Number of Persetujuan Pelaksanaan Uji Klinik (PPUK)/Persetujuan Protokol Uji BE (PPUB) | RG.01.02.321.04.25.03537/UB |
| 5. Status | |
| Countries of recruitment | Indonesia |
| Study sites in Indonesia | EQuitrust Laboratory - PT. Kimia Farma Diagnostika |
| Recruitment status | Complete |
| Date of first enrollment | 09-05-2025 |
| Targeted Sample size | 00020 - |
| Number of enrolled participants | 18 |
| Date of study completion (last participant, last visit) | 13-06-2025 |
| 6. Study Design & Purpose | |
| Primary health condition(s) or problem(s) studied (e.g., depression, breast cancer,medication error) | this study was conducted on healthy human subjects |
| Purpose of the study | The objective of this study is to establish the bioequivalence of Sitagliptin Phosphate Monohydrate 100 mg Film-Coated Tablet Produced by PT Kimia Farma Tbk Compared to JanuviaTM 100 mg Film-Coated Tablet Produced by Organon Pharma (UK) Limited, Cramlingt |
| 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) | Sitagliptin Phosphate Monohydrate 100 mg Film-Coated Tablet Produced by PT Kimia Farma Tbk |
| Control intervention (control arm) | JanuviaTM 100 mg Film-Coated Tablet Produced by Organon Pharma (UK) Limited, Cramlington, England, Registered and Packed by PT. Organon Pharma Indonesia Tbk, Pasuruan Indonesia. |
| Intervention assignment | Crossover |
| 7. Eligibility Criteria | |
| Gender inclusion criteria | Male, Female |
| Minimum age | 18 |
| Maximum age | 55 |
| Inclusion criteria | The inclusion criteria for this study include:
1) Signed informed consent; 2) Healthy based on clinical laboratory tests (routine hematology, liver function, kidney function, blood glucose, urinalysis, hepatitis B (HBsAg), hepatitis C (Anti-HCV) and HIV (Anti-HIV), medical history, and physical examination); 3) Male and female subjects (if female, consider the risks for women of childbearing age and perform pregnancy tests); 4) Age between 18-55 years; 5) Normal weight range according to Body Mass Index (BMI) 18-25 kg/m2 ); 6) Vital signs within the following ranges: systolic blood pressure 100- 129 mmHg, diastolic blood pressure 60-84 mmHg, normal pulse rate and heart rate (for ECG examination) 60-90 bpm, oxygen saturation (SpO2) in the normal range of 95- 100%, body temperature 36.5- 37.5oC, and normal respiratory rate of 12- 20/min. |
| Exclusion criteria | The exclusion criteria for this study include:
1) Smoking more than 10 cigarettes per day; 2) Pregnant or breastfeeding women. Pregnancy tests will be performed during screening and prior to the administration of the investigational or comparator drug; 3) History of kidney or liver disease, or history of allergy, hypersensitivity or contraindication to the investigational bioequivalence drug (Sitagliptin Phosphate Monohydrate); 4) Clinically significant (routine hematology, liver function, kidney function, blood glucose, urinalysis) abnormalities; 5) Abnormal electrocardiogram (ECG); 6) Difficulty accessing veins in the left or right arm; 7) History of significant ongoing clinically or medically significant chronic or acute illness; 8) History of drug or alcohol abuse within the past 12 months (1 year) prior to screening for this study; 9) Positive serology test results for Hepatitis B (HBsAg), Hepatitis C (anti-HCV), HIV (anti-HIV); 10) History or condition that can affect drug kinetics; 11) Use of drugs or dietary supplements no more than 7 days since the start of the study; 12) Participation in previous clinical trials no more than 3 months from the start of the study. The check is conducted using the checksubject.com system based on national identity number; 13) Blood donation or blood loss of more than 300 ml within 3 months from the start of the study. |
| 8. Study Outcome | |
| Primary Outcome | |
| Name of primary outcome | AUC0-t , Cmax |
| Metric/method of measurement | Bioequivalence between the test and reference products will be determined based on the average ratios of Cmax and AUC0-t with a 90% Confidence Interval (90% CI) of the log or ln-transformed data. The log or ln-transformed values of Cmax and AUC0-t for the two products are analyzed using a two-way Analysis of Variance (ANOVA) and R program. The compared factors are the drug products (Test and Reference), drug administration period (I and II), subject, and sequence (TR and RT). The mean differences in Cmax and AUC0-t between the test and reference products are considered bioequivalent if the ratio of the geometric mean (AUC)T/(AUC)R= 1.00 with 90% CI= 80.00-125.00% (α: 0.05) and (Cmax)T/(Cmax)R= 1.00 with 90% CI= 80.00-125.00% (α: 0.05). The study had a power of 80% with a significance level (alpha) of 5% (two-tailed). |
| Timepoint(s) of measurement | Blood samples were collected 17 times at the following time points: 0 hours (before drug administration); 0.25; 0.50; 1.00; 1.50; 2.00; 2.50; 3.00; 3.50; 4.00; 5.00; 8.00; 12.00; 16.00; 24.00; 36.00; and 48.00 hours after drug administration |
| Secondary outcome 1 | |
| Name of secondary outcome 1 (SO1) | AUC0-inf , tmax, half life |
| Metric/method of measurement (SO1) | Pharmacokinetic parameters, including Cmax, AUC0-t, AUC0-inf, tmax, and t1/2, were calculated for each subject and each period using the Ms. Excel program |
| Timepoint(s) of measurement (SO1) | Blood samples were collected 17 times at the following time points: 0 hours (before drug administration); 0.25; 0.50; 1.00; 1.50; 2.00; 2.50; 3.00; 3.50; 4.00; 5.00; 8.00; 12.00; 16.00; 24.00; 36.00; and 48.00 hours after drug administration |
| 9. Study Results | |
| Brief summary of study results | The present study demonstrated that the evaluated test drug Sitagliptin Phosphate Monohydrate (BN: B01A5006) were bioequivalence interm of both rate and extent of absorption to the reference drug Januvia 100 mg Film-Coated Tablet (BN: B111234) |
| Date of results summaries | 23-05-2025 |
| Participant flow | The subject recruitment process and recruitment information are disseminated
through social media ads/broadcast messages or research posters. Subjects are required to participate voluntarily, and they are free to withdraw from the study at any time. Subjects will be given detailed explanations in understandable language, including the risks and benefits of this study. Prospective subjects who meet the inclusion and exclusion criteria will be recruited as subjects after signing the informed consent form. Subjects will be given a copy of the signed consent statement. After that, subjects will be physically examined by a doctor, and clinical laboratory tests will include routine hematology, liver function, kidney function, blood glucose, urinalysis, hepatitis B (HBsAg), hepatitis C (Anti-HCV), HIV (Anti-HIV), and ECG. Verification of the signed consent will be recorded in the study's Case Report Form (CRF). |
| Baseline characteristic | |
| Adverse events | There were adverse events during this bioequivalence study, which were headache, nausea, and flatulence. All of these adverse events were recorded in the CRF |
| Outcome measures | The point estimates and 90% confidence intervals (CI) for AUC0-48h were 97.82% (95.17 – 100.53) with CV Intra Subjects was 4.71% and Cmax were 86.81% (81.09 – 92.93) with CV Intra Subjects was 11.75 |
| 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 |