Overview

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

Status:
Completed
Trial end date:
2004-11-01
Target enrollment:
0
Participant gender:
All
Summary
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 fasting conditions.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Dr. Reddy's Laboratories Limited
Treatments:
Meloxicam
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.