Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

This Study is Randomised, Single Oral Dose Bioequivalence Study of Meloxicam GSK 15 MG Tablets. (BA/BE: 250/12)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01750931
First received: November 28, 2012
Last updated: November 27, 2013
Last verified: October 2013
  Purpose

It is a randomized, balanced, open label, crossover, two period, two treatment, two sequence, single dose, oral bioequivalence study of Meloxicam GSK 15 mg tablets manufactured by Savipharm J.S.Cc, 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. It is a pivotal study to demonstrate the bioequivalence 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.

This study will enroll 28 healthy adult human male subjects


Condition Intervention Phase
Arthritis, Rheumatoid
Drug: Meloxicam GSK 15mg
Drug: Mobic 15mg
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Cmax, Tmax, AUC0-t, AUC0-∞, AUC%_Extrap, Kel and t1/2 [ Time Frame: 7days ] [ Designated as safety issue: No ]
    Statistical analyses will be done using SAS® version 9.2 or higher. Analysis of variance [ANOVA] for log-transformed pharmacokinetic parameters [Cmax, AUC0-t and AUC0-∞] and two one-sided tests [Schuirmann] for bioequivalence will be performed. Power, ratio and 90% confidence interval for log-transformed pharmacokinetic parameters - Cmax, AUC0-t and AUC0-∞ will be calculated.


Secondary Outcome Measures:
  • Safety profile [ Time Frame: Post study AEs will be collected for 7 days post last dose and SAEs will be collected for 30 days post last dose ] [ Designated as safety issue: Yes ]
    AEs will be collected from the start of Study Treatment and until the follow-up contact. Medical occurrences that begin prior to the start of study treatment but after obtaining informed consent may be recorded on the Medical History/Current Medical Conditions CRF.SAEs will be collected over the same time period as stated above for AEs.


Enrollment: 28
Study Start Date: September 2013
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Meloxicam GSK 15mg
A randomized, balanced, open label, crossover, two period, two treatment, two sequence, single dose, oral bioequivalence study under fed condition
Drug: 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
Drug: Mobic 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
A randomized, balanced, open label, crossover, two period, two treatment, two sequence, single dose, oral bioequivalence study under fed condition
Drug: 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
Drug: Mobic 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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male human subjects within the age range of 18 to 45 years inclusive.
  • Heght not less than 50 kg.
  • Normal BMI [18.5 to 24.99 kg/m2 inclusive].
  • Willingness and capability to provide written informed consent to participate in the study.
  • Free of significant diseases or clinically significant abnormal findings based on medical history, physical examination, laboratory evaluations, 12-lead ECG, Chest X-ray [PA view].
  • Absence of disease markers of HIV 1 and 2, Hepatitis B and C and Syphilis.
  • AST, ALT, alkaline phosphatase and bilirubin ≤ 1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
  • ECG normal for morphology and measurements. QTcB or QTcF < 450 msec or QTc < 480 msec in subjects with Bundle Branch Block, based on an average from three ECGs obtained over a brief recording period.
  • Male subjects with female partners of child-bearing potential must agree to use one of the contraception methods listed below. This criterion must be followed from the time of the first dose of study medication until one week of last dose administration.
  • Condom plus partner use of a highly effective contraceptive such as occlusive cap (diaphragm or cervical/vault cap) plus spermicidal agent (foam/gel/film/cream/suppository), oral contraceptive, injectable progesterone, implant of etonogestrel or levonorgestrel, estrogenic vaginal ring, percutaneous contraceptive patches, or intrauterine device.

OR

  • Abstinence, defined as sexual inactivity consistent with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.

Exclusion Criteria:

  • History or presence of significant: Cardiovascular, pulmonary, hepatic, renal, hematological, gastro-intestinal, endocrine, immunologic, dermatologic, neurological, psychiatric disease.
  • History or presence of significant:
  • Alcohol dependence or alcohol abuse during past one year.
  • Drug abuse [Marijuana [THC], Cocaine, Morphine, Benzodiazepines, Barbiturates and Amphetamine] for the last 6 months.
  • Smoking of more than 5 cigarettes per day or consumption of other forms of tobacco containing products.
  • Asthma, urticaria or other allergic type reactions after taking aspirin or any other drug.
  • Ulceration or history of gastric and / or duodenal ulcer.
  • Jaundice in the past 6 months.
  • Bleeding disorder.
  • Allergy to the test drug or any drug chemically similar to the drug or to the excipients of the products under investigation.
  • Donation of 500 mL or more blood within 8 weeks prior to receiving the first dose of study drug.
  • The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
  • Any difficulty in accessibility of forearm veins for cannulation or blood sampling.
  • Refusal to consume high calorie high fat breakfast 30 minutes before scheduled dosing time and abstain from food for at least 5 h post dose in each period.
  • Refusal to abstain from fluid for at least 1 h prior to and 1 h post each dose.
  • Positive breath alcohol test result found on the day of check-in.
  • Positive urine test result for drug of abuse found on the day of check-in.
  • History of difficulty in swallowing tablet.
  • Use of any concomitant medication [including over-the-counter products, vitamins etc.] for 14 days preceding the study drug administration.
  • Use of drugs which induce or inhibit metabolizing enzymes within 30 days prior to receiving the first dose of study medication.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01750931

Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01750931     History of Changes
Other Study ID Numbers: 117176
Study First Received: November 28, 2012
Last Updated: November 27, 2013
Health Authority: India: Independent Ethics Committee

Keywords provided by GlaxoSmithKline:
BE study of Meloxicam GSK 15mg

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Arthritis
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Meloxicam
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014