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CompletedNCT01161147Updated Jul 13, 2010

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

A Phase 1 interventional study of Meloxicam in Healthy, sponsored by Dr. Reddy's Laboratories Limited. Completed at 1 site in Canada. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-07-13.

Sponsored by Dr. Reddy's Laboratories Limited · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
28
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study 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 fed conditions.

Read the 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.

02

Conditions studied

  • Healthy

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03

In context

Malnutrition

1,587 studies on the registry are indexed under Malnutrition; 237 are open to participants now.

This study's enrollment of 28 is below the median of 90 across 1,134 interventional studies indexed under Malnutrition.

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Lead sponsor

Dr. Reddy's Laboratories Limited is the lead sponsor of 220 studies on the registry; 2 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 11 (85%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
28 participants (actual)

Study arms

  • Experimental
    Meloxicam

    Meloxicam Tablets 15 mg of Dr.Reddy's Laboratories Limited

    Drug: Meloxicam

  • Active comparator
    Mobic

    Mobic Tablets 15 mg of Boehringer Ingelheim Pharmaceuticals Inc

    Drug: Meloxicam

Interventions

  • DrugMeloxicam

    Meloxicam Tablets 15 mg

    Also known as: Mobic Tablets 15 mg

06

What researchers measure

Primary outcomes

  1. Bioequivalence on Cmax and AUC parameters

    Time frame: 4 months

07

Study locations

1 site
  • Allied Research International Inc.
    Mississauga, Ontario L4W 1N2, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 13, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01161147
Lead sponsor
Dr. Reddy's Laboratories Limited
First posted
Jul 13, 2010
Start date
Oct 2004
Primary completion
Dec 2004
Completion
Dec 2004
Last update
Jul 13, 2010

Study contacts

Deepen M Patel, M.D., C.C.F.P.
principal investigator · Allied Research International Inc.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2004. You cannot join it, but the record below documents what was studied.

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