Bioequivalence Study of Meloxicam Tablets 15 mg of Dr.Reddy's Laboratories Limited Under Fed Condition

This study has been completed.
Sponsor:
Information provided by:
Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier:
NCT01161147
First received: July 12, 2010
Last updated: NA
Last verified: August 2004
History: No changes posted
  Purpose

The objective of this study is to determine the relative bioavailability of one 15 mg Meloxicam tablet (Dr. Reddy. Laboratories Ltd.,Generics) versus one 15 mg Mobic (meloxicam) Tablet (Boehringer Ingelheim Pharmaceuticals Inc., USA) under fed conditions.


Condition Intervention Phase
Healthy
Drug: Meloxicam
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparative Bioavailability Study of Meloxicam 15 mg Tablets (Dr. Reddy's Laboratories Ltd., Generics) Vs. Mobic® 15 mg Tablets (Boehringer Ingelheim Pharmaceuticals Inc.,Usa) in Healthy Male And/Or Female Volunteers Under Fed Conditions- P1CX04002

Resource links provided by NLM:


Further study details as provided by Dr. Reddy's Laboratories Limited:

Primary Outcome Measures:
  • Bioequivalence on Cmax and AUC parameters [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Enrollment: 28
Study Start Date: October 2004
Study Completion Date: December 2004
Primary Completion Date: December 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Meloxicam
Meloxicam Tablets 15 mg of Dr.Reddy's Laboratories Limited
Drug: Meloxicam
Meloxicam Tablets 15 mg
Other Name: Mobic Tablets 15 mg
Active Comparator: Mobic
Mobic Tablets 15 mg of Boehringer Ingelheim Pharmaceuticals Inc
Drug: Meloxicam
Meloxicam Tablets 15 mg
Other Name: Mobic Tablets 15 mg

Detailed Description:

Twenty eight (twenty six study subjects + two alternate subjects)healthy male and/or female subjects participated in an open label, two-period, two-sequence, two- treatment,single dose, two-way crossover study with at least 14 days washout between doses conducted under fed conditions.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. The subject must be a healthy male or female volunteer.If the volunteer is female. she must demonstrate β-CG levels consistent with the nongravid state at the medical screening visit and at check-in for Period 1 and agree to remain abstinent or use double-barrier contraception (partner using condom and female volunteer using diaphragm, contraceptive sponge, spermicide, or IUD). If the female is post-menopausal or is surgically sterile, she is exempt from this requirement. (Postmenopausal is defined as no menses for the previous 1 year. If cessation of menses is within 18 months, FSH and/or LH must be documented prestudy as elevated into the postmenopausal range.).
  2. The subject must be between the ages of 18 - 55 years old (inclusive).
  3. The Subject's body mass index (BMI) must be within 19.0 - 30.0 (Kg/m2).
  4. The subject must be a non-smoker and not using any nicotine products.
  5. The subject must sign the written consent form (Research Subject Information and Consent Form) prior to study entry.
  6. The subject must have clinically acceptable results from the screening procedure including blood pressure, heart rate, ECG, physical exam, medical history, hematology, biochemistry, urinalysis. and infection screen (Hepatitis B Antigen, Hepatitis C Antibody, HIV)

Exclusion Criteria:

  1. Subjects with a history of clinically significant gastro-intestinal, dermatological, cardiovascular, renal, hematological, neurological, hepatic, pulmonary, or endocrine disease in the last 12 months.
  2. Subjects determined by the Investigator to have any medical condition which may affect the absorption, distribution, metabolism or excretion of the investigational product, or that could jeopardize their health or prejudice the results (e.g. history of surgery of the gastro-intestinal tract, except for appendectomy).
  3. Subjects with a known allergy to meloxicam (Mobic) or other nonsteroidal anti-inflammatory drugs (NSAIDS) [e.g. Motrin® (ibuprofen), Celebrex® (celecoxib). Vioxx® (rofecoxib). Naprelan® and Anaprox®, (naproxen sodium), Lodine® (etodolac), Cataflam® (diclofenac potassium). Voltaren® and Arthrotec®(diclofenac sodium), etc.].
  4. Females who are pregnant, breastfeeding, or are likely to become pregnant.
  5. Subjects with any clinically significant illness within four weeks prior to Period 1 dosing.
  6. Subjects with a positive saliva alcohol test at check-in for any period.
  7. Subjects with a history of alcohol, drug or substance abuse in the past 12 months.
  8. Subjects who have used any prescription medication within 14 days of Period 1 dosing or over-the-counter medication within 14 days of Period 1 dosing.
  9. Subjects deemed uncooperative or noncompliant.
  10. Subjects who have consumed alcohol within 48 hours prior to Period 1 and Period 2 dosing.
  11. Subjects who have consumed xanthine-containing products (including caffeine, theobromines, etc.) within 48 hours prior to Period 1 dosing.
  12. Subjects who have consumed food or beverages containing grapefruit (e.g. fresh, Canned, or frozen) within 14 days prior to the administration of the study medication.
  13. Subjects who have had an abnormal diet within 30 days prior to Period 1 dosing.
  14. Subjects who have participated in an investigational drug study or who have donated more than 100 mL of blood within 30 days prior to Period 1 dosing.
  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: NCT01161147

Locations
Canada, Ontario
Allied Research International Inc.
Mississauga, Ontario, Canada, L4W 1N2
Sponsors and Collaborators
Dr. Reddy's Laboratories Limited
Investigators
Principal Investigator: Deepen M Patel, M.D., C.C.F.P. Allied Research International Inc.
  More Information

No publications provided

Responsible Party: Group leader-Research & Development, Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier: NCT01161147     History of Changes
Other Study ID Numbers: P1CX04002
Study First Received: July 12, 2010
Last Updated: July 12, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Meloxicam
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 30, 2014