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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01161134
• Date of registration: 12/07/2010
• Prospective Registration: No
• Primary sponsor: Dr. Reddy's Laboratories Limited
• Public title: Bioequivalence Study of Meloxicam Tablets 15 mg of Dr.Reddy's Laboratories Limited Under Fasting Condition
• Scientific 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 Fasting Conditions-P1cx04001
• Date of first enrolment: September 2004
• Target sample size: 28
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01161134
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

Canada

Contacts

• Name: Deepen M Patel, M.D., C.C.F.P.
• Affiliation: Allied Research International Inc.

Key inclusion & exclusion criteria

Inclusion Criteria:

1. The subject must be a healthy male or female volunteer.If the volunteer is female.
she must demonstrate ß-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.



Age minimum: 18 Years
Age maximum: 55 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Healthy

Intervention(s)

Drug: Meloxicam

Primary Outcome(s)

Bioequivalence on Cmax and AUC parameters [Time Frame: 4 months]

Secondary ID(s)

P1CX04001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors