- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01161147
Bioequivalence Study of Meloxicam Tablets 15 mg of Dr.Reddy's Laboratories Limited Under Fed Condition
July 12, 2010 updated by: Dr. Reddy's Laboratories Limited
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
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
28
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Mississauga, Ontario, Canada, L4W 1N2
- Allied Research International Inc.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.).
- The subject must be between the ages of 18 - 55 years old (inclusive).
- The Subject's body mass index (BMI) must be within 19.0 - 30.0 (Kg/m2).
- The subject must be a non-smoker and not using any nicotine products.
- The subject must sign the written consent form (Research Subject Information and Consent Form) prior to study entry.
- 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:
- Subjects with a history of clinically significant gastro-intestinal, dermatological, cardiovascular, renal, hematological, neurological, hepatic, pulmonary, or endocrine disease in the last 12 months.
- 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).
- 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.].
- Females who are pregnant, breastfeeding, or are likely to become pregnant.
- Subjects with any clinically significant illness within four weeks prior to Period 1 dosing.
- Subjects with a positive saliva alcohol test at check-in for any period.
- Subjects with a history of alcohol, drug or substance abuse in the past 12 months.
- 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.
- Subjects deemed uncooperative or noncompliant.
- Subjects who have consumed alcohol within 48 hours prior to Period 1 and Period 2 dosing.
- Subjects who have consumed xanthine-containing products (including caffeine, theobromines, etc.) within 48 hours prior to Period 1 dosing.
- 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.
- Subjects who have had an abnormal diet within 30 days prior to Period 1 dosing.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Meloxicam
Meloxicam Tablets 15 mg of Dr.Reddy's Laboratories Limited
|
Meloxicam Tablets 15 mg
Other Names:
|
ACTIVE_COMPARATOR: Mobic
Mobic Tablets 15 mg of Boehringer Ingelheim Pharmaceuticals Inc
|
Meloxicam Tablets 15 mg
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Bioequivalence on Cmax and AUC parameters
Time Frame: 4 months
|
4 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2004
Primary Completion (ACTUAL)
December 1, 2004
Study Completion (ACTUAL)
December 1, 2004
Study Registration Dates
First Submitted
July 12, 2010
First Submitted That Met QC Criteria
July 12, 2010
First Posted (ESTIMATE)
July 13, 2010
Study Record Updates
Last Update Posted (ESTIMATE)
July 13, 2010
Last Update Submitted That Met QC Criteria
July 12, 2010
Last Verified
August 1, 2004
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nutrition Disorders
- Malnutrition
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Cyclooxygenase 2 Inhibitors
- Meloxicam
Other Study ID Numbers
- P1CX04002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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