A randomized, balanced, open label, crossover, two period, two treatment, two sequence, single dose, oral bioequivalence study under fed condition

In each period of the study, participants received a single oral dose of test (GSK-meloxicam 15 mg tablet) or reference (Mobic-meloxicam 15 mg tablet) product as per the randomization schedule with 240 mL of water 30 minutes after start of consumption of high fat high calorie breakfast on an overnight fast of at least 10 hours. Dosing was scheduled at specific intervals between 08:30 am to 08:56 am in each study period. A washout period of 14 days was maintained between the dosing of each period.

GSK-meloxicam 15 mg + Mobic-meloxicam 15 mg

Sex: Female, Male

Region of Enrollment

Plasma samples for pharmacokinetic (PK) analysis were drawn at indicated time points of each treatment period. The Cmax was taken directly from the plasma concentration-time profile of individual participants

In each period of the study, participants received a single oral dose of test product (GSK-meloxicam 15 mg tablet) as per the randomization schedule with 240 mL of water 30 minutes after start of consumption of high fat high calorie breakfast on an overnight fast of at least 10 hours. Dosing was scheduled at specific intervals between 08:30 am to 08:56 am in each study period.

GSK-meloxicam 15 mg

In each period of the study, participants received a single oral dose of reference (Mobic-meloxicam 15 mg tablet) as per the randomization schedule with 240 mL of water 30 minutes after start of consumption of high fat high calorie breakfast on an overnight fast of at least 10 hours. Dosing was scheduled at specific intervals between 08:30 am to 08:56 am in each study period.

Mobic-meloxicam 15 mg

Maximum Drug Concentration During the Selected Dosing Interval (Cmax) After a Single Dose

Plasma samples for PK analysis were drawn at indicated time points of each treatment period. The Tmax was taken directly from the plasma concentration-time profile of individual participants. Plasma samples for PK analysis were drawn at indicated time points.

Time to Maximum Concentration (T-max)

Plasma samples for PK analysis were drawn at indicated time points of each treatment period. AUC(0-t) was area under the plasma concentration-time curve from time of administration until the time of last quantifiable concentration. The area under the plasma concentration-time curve (AUC0-infinity), was estimated by linear trapezoidal rule and was sum of the AUC0-t and extrapolated to infinity by dividing the estimated last measurable plasma concentration by elimination rate constant lambda z. Where lambda z is the terminal phase rate constant estimated by linear regression analysis of the log transformed concentration-time data after each single dose. The AUC0-infinity was the sum of the estimated and extrapolated parts.

The Area Under the Plasma Concentration Versus Time Curve (AUC) After a Single Dose

Plasma samples for PK analysis were drawn at indicated time points of each treatment period. The percentage of area under curve extrapolated to arrive at AUC0-infinity (AUC%_Extrap [residual area]) was determined by AUC0-infinity minus AUC0-t divided by AUC0-infinity multiplied by 100.

The Percentage of Area Under Curve Extrapolated to Arrive at AUC0-infinity (AUCpercentage [%]_Extrap [Residual Area]) After a Single Dose

Plasma samples for PK analysis were drawn at indicated time points of each treatment period. The apparent first-order elimination or terminal rate constant was calculated from a semilogarithmic plot of the plasma concentration versus time. The parameter was calculated by linear least-square regression analysis using the last three (or more) non-zero plasma concentrations.

Elimination Rate Constant (Kel) After a Single Dose

The T-half was calculated using the following formula by dividing 0.693 (natural logarithm of 2) with lambda z, where lambda z is the terminal phase rate constant estimated by linear regression analysis of the log transformed concentration-time data after each single dose.

Elimination Half Life (T-half) After a Single Dose

An AE was defined as any untoward medical occurrence (MO) in a participant temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product and can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with its use. The SAE was any untoward MO that, at any dose, results in death, life threatening, persistent or significant disability/incapacity, results in or prolongs inpatient hospitalization, congenital abnormality or birth defect, is medically important event or reaction, is associated with liver injury Alanine amino transferase (more than equal to [>=] 3 fold upper normal of limit [ULN]) or total bilirubin (>=2 fold ULN) or international normalization ratio more than 1.5. Refer to the general AE/SAE module for a list of AEs and SAEs.

Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)

In this period of the study, participants received a single oral dose of test (GSK-meloxicam 15 mg tablet) followed by reference (Mobic-meloxicam 15 mg tablet) product as per the randomization schedule with 240 milliliters (mL) of water 30 minutes after start of consumption of high fat high calorie breakfast on an overnight fast of at least 10 hours. Dosing was scheduled at specific intervals between 08:30 ante meridiem (am) to 08:56 am in each study period. A washout period of 14 days was maintained between the dosing of each period.

GSK-meloxicam Then Mobic-meloxicam

In this period of the study, participants received a single oral dose of reference (Mobic-meloxicam 15 mg tablet) followed by test (GSK-meloxicam 15 mg tablet) product as per the randomization schedule with 240 milliliters (mL) of water 30 minutes after start of consumption of high fat high calorie breakfast on an overnight fast of at least 10 hours. Dosing was scheduled at specific intervals between 08:30 ante meridiem (am) to 08:56 am in each study period. A washout period of 14 days was maintained between the dosing of each period.

Mobic-meloxicam Then GSK-meloxicam

Period 1

Wash Out

Period 2

GSK Response Center

Arthritis, Rheumatoid

To demonstrate the bioequivalence of Meloxicam 15 mg tablets manufactured by Savipharm J.S.C, Vietnam and Mobic® 15 mg tablets of Boehringer Ingelheim Pharma GmbH &amp; Co.KG Binger Str.173, 5521 Ingelheim am Rhein, Germany, in healthy adult human male subjects under fed condition

Meloxicam GSK 15mg

To demonstrate the bioequivalence of Meloxicam 15 mg tablets manufactured by Savipharm J.S.C, Vietnam and Mobic® 15 mg tablets of Boehringer Ingelheim Pharma GmbH & Co.KG Binger Str.173, 5521 Ingelheim am Rhein, Germany, in healthy adult human male subjects under fed condition

Mobic 15mg

This Study is Randomised, Single Oral Dose Bioequivalence Study of Meloxicam GSK 15 MG Tablets.

AN OPEN LABEL, BALANCED, RANDOMIZED, TWO-TREATMENT, TWO-PERIOD, TWO-SEQUENCE, CROSSOVER, SINGLE ORAL DOSE, BIOEQUIVALENCE STUDY OF MELOXICAM GSK 15 MG TABLETS MANUFACTURED BY SAVIPHARM J.S.C, VIETNAM AND MOBIC® 15 MG TABLETS OF BOEHRINGER INGELHEIM PHARMA GMBH & CO. KG BINGER STR.173, 5521 INGELHEIM AM RHEIN, GERMANY, IN HEALTHY, ADULT, HUMAN MALE SUBJECTS UNDER FED CONDITION.

rhein/karijes

This Study is Randomised, Single Oral Dose Bioequivalence Study of Meloxicam GSK 15 MG Tablets.

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