Bioequivalence Study of Meloxicam 15 mg Tablet Produced by PT Trifa Raya Laboratories in Comparison with Mobic® (Meloxicam 15 mg) Tablet Produced by Boehringer Ingelheim Pty Limited, Australia
| 1. Background | |
|---|---|
| Registration Number | INA-XO4B1RT |
| Date of registry approval | 07-10-2024 |
| Registration Date | 03-10-2024 |
| Secondary identifiers | Yes |
| Name of issuing authority (for example protocol number, other registries, etc) | 10/PRO-BE/FLIU/XII/2023 |
| Secondary identifier number | PPUB: RG.01.02.321.06.24.02691/UB |
| Scientific study title | Bioequivalence Study of Meloxicam 15 mg Tablet Produced by PT Trifa Raya Laboratories in Comparison with Mobic® (Meloxicam 15 mg) Tablet Produced by Boehringer Ingelheim Pty Limited, Australia |
| Public (popular study title) | Bioequivalence Study of Meloxicam 15 mg Tablet Produced by PT Trifa Raya Laboratories in Comparison with Mobic® (Meloxicam 15 mg) Tablet Produced by Boehringer Ingelheim Pty Limited, Australia |
| 2. Sponsor and Funding | |
| Primary Sponsor | PT Trifa Raya Laboratories |
| Source(s) of monetary or material support | PT Trifa Raya Laboratories |
| Other partners | |
| 3. Contact details | |
| Principal Investigator | |
| Principal investigator | Prof. Dr. apt. Keri Lestari Dandan, M.Si. |
| City | Bandung |
| Country | Indonesia |
| Principal investigator's affiliation | PT Farmalab Indoutama |
| Principal Investigator's email address | ric.farmalab.bdg@gmail.com |
| Public Queries | |
| Contact person name for public queries | apt. Eva Sumiyarni, S.Si. |
| Address for public queries | Jl. Prof. Eyckman No. 38 |
| City | Bandung |
| Country | Indonesia |
| ZIP | 40161 |
| Affiliation for public queries | PT Farmalab Indoutama |
| Email address for public queries | ric.farmalab.bdg@gmail.com |
| Phone number for public queries | 081318660305 |
| Scientific Queries | |
| Name of Contact for scientific queries | apt. M. Akbar Emberik, S.Farm., M.Si. |
| Address for scientific queries | Jl. Prof. Eyckman No. 38 |
| City | Bandung |
| Country | Jawa Barat |
| ZIP | 40161 |
| Affiliation of scientific queries contact | PT Farmalab Indoutama |
| Email address for scientific queries | ric.farmalab.bdg@gmail.com |
| 4. IRB & Regulatory | |
| Ethical Approval number | 544/UN6.KEP/EC/2024 |
| Name of Ethics committee | Komite Etik Penelitian Universitas Padjadjaran |
| Date of Ethic approval | 14-05-2024 |
| Contact details of Ethic Committee (phone, email, and office) | Jl. Prof. Eyckman No. 38, Bandung; Telp. & Fax. 022-2038697; email: kep@unpad.ac.id |
| Number of Persetujuan Pelaksanaan Uji Klinik (PPUK)/Persetujuan Protokol Uji BE (PPUB) | RG.01.02.321.06.24.02691/UB |
| 5. Status | |
| Countries of recruitment | Indonesia |
| Study sites in Indonesia | PT Farmalab Indoutama |
| Recruitment status | Complete |
| Date of first enrollment | 19-06-2024 |
| Targeted Sample size | 00016 - |
| Number of enrolled participants | 16 |
| Date of study completion (last participant, last visit) | 06-07-2024 |
| 6. Study Design & Purpose | |
| Primary health condition(s) or problem(s) studied (e.g., depression, breast cancer,medication error) | Healthy human volunteers |
| Purpose of the study | Other |
| 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) | Meloxicam 15 mg Tablet Produced by PT Trifa Raya Laboratories |
| Control intervention (control arm) | Mobic® (Meloxicam 15 mg) Tablet Produced by Boehringer Ingelheim Pty Limited, Australia |
| Intervention assignment | Crossover |
| 7. Eligibility Criteria | |
| Gender inclusion criteria | Male, Female |
| Minimum age | 18 |
| Maximum age | 55 |
| Inclusion criteria | Willing to sign informed consent, healthy subjects as determined by the medical laboratory test (routine hematology, liver function, renal function, blood glucose, urinalysis), medical history, and physical examination (result that are not in normal range but clinically insignificant by medical doctor justification could be considered healthy), male or female, age between 18-55 years, normal body weight (Body Mass Index= 18-25 kg/m2), blood pressure: systolic 100-129 mmHg, diastolic 60-84 mmHg, pulse rate 60-90 bpm, have received the primary SARS-CoV-2 vaccine complete and at least the first booster or SARS-CoV-2 antigen rapidtest give a nonreactive result. |
| Exclusion criteria | History of allergy or hypersensitivity or contraindication to meloxicam, any major illness in the past 90 days or clinically significant ongoing chronic medical illness, history of drug or alcohol abuse, participation in any clinical trial or blood donation or significant blood loss more than 300 mL within the past 90 days prior study, positive Hepatitis B surface antigen (HBsAg), anti-HCV, or anti-HIV, pregnant or lactating female (urinary pregnancy test applied to female subjects at screening and before taking the study drug at Period I and II), any medical condition (present or history) which might affect drug kinetics e.g history of gastric surgery, intestinal digestive disorder, smoking more than 10 (ten) cigarettes per day, history of major illness, e.g. heart failure, hepatitis, hypotension, hyperglycemia, hypertension, etc., intake of any drug or food supplements less than 7 days since the start of study, abnormal electrocardiogram (ECG), history of close contact with Covid-19 patients within 14 days prior study |
| 8. Study Outcome | |
| Primary Outcome | |
| Name of primary outcome | AUC0-t dan Cmax |
| Metric/method of measurement | Bioequivalence of the test and reference product formulations is assessed by calculating individual AUCt and Cmax values. The mean ratio (test/reference) of the ln-transformed data and their 90% confidence intervals is analyzed with a parametric method (analysis of variance/ANOVA) using R Statistical Software Version 4.2.2 |
| Timepoint(s) of measurement | Predose, 1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours after drug administration |
| Secondary outcome 1 | |
| Name of secondary outcome 1 (SO1) | AUC0-inf , Tmax, Half life |
| Metric/method of measurement (SO1) | The difference in Tmax analyzed by using non-parametrically on the original data Wilcoxon matched-pairs test. The t½ difference analyzed by using Student’s paired t-test or Wilcoxon matched-pairs test depending whether the differences of the paired data were distributed normally or not. |
| Timepoint(s) of measurement (SO1) | Predose, 1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours after drug administration |
| 9. Study Results | |
| Brief summary of study results | The 90% Confidence Intervals for the log-transformed ratios (Test/Reference) for Cmax and AUC0-t were within 80.00-125.00%. Therefore, Meloxicam 15 mg Tablet Produced by PT Trifa Raya Laboratories is bioequivalent to Mobic® (Meloxicam 15 mg) Tablet Produced by Boehringer Ingelheim Pty Limited, Australia |
| Date of results summaries | 13-09-2024 |
| Participant flow | Period 1: Dosing = 16, Dropout = 0, Completed = 16 subjects
Period 2: Withdrew = 1, Dosing = 15, Dropout = 0, Completed = 15 subjects |
| Baseline characteristic | |
| Adverse events | No adverse events occurred |
| Outcome measures | Geomean ratio T/R (90%CI), %ISCV
Cmax = 105.85% (92.11 - 121.63%), 21.69% AUCt = 101.40% (94.25 - 109.08%), 11.30% |
| 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)) | |
| Plan for IPD sharing (what IPD will be shared, when, by what mechanism, with whom, and for what types of analyses) | |
| Other important informations | |