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| Sponsor: | Mylan Pharmaceuticals |
|---|---|
| Information provided by: | Mylan Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00649077 |
Purpose
The objective of this study was to investigate the bioequivalence of Mylan's meloxicam 15 mg tablets and Boehringer Ingelheim's Mobic® 15 mg tablets following a single, oral 15 mg (1 x 15 mg) dose administration under fasting conditions.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: Meloxicam Tablets 15 mg Drug: Mobic® Tablets 15 mg |
Phase I |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Crossover Assignment Masking: Open Label |
| Official Title: | Single-Dose Fasting In Vivo Bioequivalence Study of Meloxicam Tablets (15 mg; Mylan) and Mobic® Tablets (15 mg; Boehringer Ingelheim) in Healthy Volunteers |
| Enrollment: | 30 |
| Study Start Date: | August 2004 |
| Study Completion Date: | September 2004 |
| Primary Completion Date: | September 2004 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Meloxicam Tablets 15 mg
|
Drug: Meloxicam Tablets 15 mg
15mg, single dose fasting
|
|
Active Comparator: 2
Mobic® Tablets 15 mg
|
Drug: Mobic® Tablets 15 mg
15mg, single dose fasting
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Sex: Male and non-pregnant, non-lactating female.
Women must practice abstinence or be using an acceptable form of contraception throughout the study. No hormonal contraceptives or hormonal replacement therapies are permitted in this study. Acceptable forms of contraception include the following:
Women will not be considered of childbearing potential if one of the following is reported and documented on the medical history:
Exclusion Criteria:
Social Habits:
Medications:
Diseases:
Abnormal and clinically significant laboratory test results:
Contacts and Locations| United States, West Virginia | |
| Kendle International Inc. | |
| Morgantown, West Virginia, United States, 26505 | |
| Principal Investigator: | Dorian Williams, M.D. | Kendle International Inc. |
More Information
| Responsible Party: | Will Sullvan, Global Head of Product Risk and Safety Management, Mylan Inc. |
| ClinicalTrials.gov Identifier: | NCT00649077 History of Changes |
| Other Study ID Numbers: | MELO-0443 |
| Study First Received: | March 30, 2008 |
| Last Updated: | March 31, 2008 |
| Health Authority: | United States: Institutional Review Board |
|
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 |