BIOEQUIVALENCE STUDY OF LOXIL 15 MG TABLET MANUFACTURED BY PT GRACIA PHARMINDO IN COMPARISON WITH MOBIC® 15 MG TABLET MANUFACTURED BY ROTTENDORF PHARMA GMBH, GERMANY, MARKETING AUTHORIZATION HOLDER BY BOEHRINGER

Tahapan Penelitian : Initial
Sponsor:
Mitra Pelaksana:
PT. Pharma Metric Labs
No Registry
INA-E1RAR8P
Tanggal Input Registry : 24-07-2024

01-05-2024
The result of Loxil 15 mg tablet (test product) in comparison with Mobic® 15 mg tablet (reference drug) were as following: 90.00% confidence intervals of geometric means ratio of the two bioavailability parameters of meloxicam were 101.89% – 123.25% for Cmax and 97.77% – 110.94% for AUCt. These results showed that Loxil 15 mg tablet was bioequivalent toward its reference product, Mobic® 15 mg tablet.
 
BIOEQUIVALENCE STUDY OF LOXIL 15 MG TABLET MANUFACTURED BY PT GRACIA PHARMINDO IN COMPARISON WITH MOBIC® 15 MG TABLET MANUFACTURED BY ROTTENDORF PHARMA GMBH, GERMANY, MARKETING AUTHORIZATION HOLDER BY BOEHRINGER
BIOEQUIVALENCE STUDY OF LOXIL 15 MG TABLET MANUFACTURED BY PT GRACIA PHARMINDO IN COMPARISON WITH MOBIC® 15 MG TABLET MANUFACTURED BY ROTTENDORF PHARMA GMBH, GERMANY, MARKETING AUTHORIZATION HOLDER BY BOEHRINGER
Interventional
14
 

Inclusion Criteria:

- Have read the subject information and able to give written informed consent for participation in the study and comply with the study protocol/procedures. - Healthy male and female - Age between 18 – 55 years - Body Mass Index (BMI) between 18–25 kg/m2 - Having a normal electrocardiogram - 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 - ESH Guidelines for the Management of Arterial Hypertension (2018)) - Have no significant disease or clinically significant abnormal laboratory values on laboratory evaluation, medical history or physical examination during screening. - Have received the complete primary SARS CoV-2 vaccine. - Negative result of SARS CoV-2 antigen test (for those who has not received the first booster vaccine)

Exclusion Criteria:

- Pregnant and/or nursing woman - Having history of hypersensitivity or contraindication to meloxicam, 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 - Having 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 any cardiovascular disease. - Having history or presence of any coagulation disorder or clinically significant hematology abnormalities - Having history or presence of recurrent ulcer/hemorrhage, or gastrointestinal bleeding or perforation - Disagree to use non-hormonal contraceptives methods (condom) before any intercourse with their spouse throughout study period. - 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. - Participated in any clinical study within the past 90 days prior to the study. - Donated or losing 300 mL (or more) of blood within 3 months prior to the study - Smoker - History of direct contact with a COVID-19 positive person in the subject’s neighborhood within 14 days prior to screening - History or present of sore throat, fever (with temperature more than 37°C), cough, cold, anosmia/loss of smell, or dyspnea within the last 14 days - Positive to HIV, HBsAg, and HCV tests (to be kept confidential). - History of drug or alcohol abuse within 12 months prior to screening for this study - Unlikely to comply with the protocol, e.g. uncooperative attitude, inability to return for follow up visits, poor venous access
 
KET-455/UN2.F1/ETIK/PPM.00.02/2024
Not applicable
PPUK/PPUB number
PT. Gracia Pharmindo