Fasting Study of Olanzapine Tablets 20 mg and Zyprexa® Tablets 20 mg
This study has been terminated.
(during Period 1 due to numerous orthostatic AEs that occurred. Subsequently, RLD was reduced to 5 mg due to safety concerns.)
Sponsor:
Mylan Pharmaceuticals
Information provided by:
Mylan Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00647972
First received: March 30, 2008
Last updated: November 19, 2009
Last verified: November 2009
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Purpose
The objective of this study was to investigate the bioequivalence of Mylan olanzapine 20 mg tablets to Eli Lilly Zyprexa® 20 mg tablets following a single, oral 20 mg (1 x 20 mg) dose administration under fasting conditions.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: Olanzapine Tablets 20 mg Drug: Zyprexa® Tablets 20 mg |
Phase 1 |
| 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 Olanzapine Tablets (20 mg; Mylan) and Zyprexa® Tablets (20 mg; Eli Lilly) in Healthy Volunteers |
Resource links provided by NLM:
Further study details as provided by Mylan Pharmaceuticals:
Primary Outcome Measures:
- The 90% confidence interval for the LSMeans ratio of CPEAK, AUCL, and AUCI for the test and reference product should be between 80.00% and 125.00% for the natural log-transformed data. [ Time Frame: blood collections through 144 hours ] [ Designated as safety issue: No ]
| Enrollment: | 32 |
| Study Start Date: | May 2003 |
| Primary Completion Date: | May 2003 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Olanzapine Tablets 20 mg
|
Drug: Olanzapine Tablets 20 mg
20mg, single dose fasting
|
|
Active Comparator: 2
Zyprexa® Tablets 20 mg
|
Drug: Zyprexa® Tablets 20 mg
20mg, single dose fasting
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- healthy, adult subjects, 18 years and older
- able to swallow medication
Exclusion Criteria:
- institutionalized subjects
- history of any significant disease
- use of any prescription or OTC medications within 14 days of start of study
- received any investigational products within 30 days prior to start of study
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00647972
Locations
| United States, West Virginia | |
| Kendle International Inc. | |
| Morgantown, West Virginia, United States, 26505 | |
Sponsors and Collaborators
Mylan Pharmaceuticals
Investigators
| Principal Investigator: | Thomas S Clark, M.D. | Kendle International Inc. |
More Information
Additional Information:
No publications provided
| Responsible Party: | Wayne Talton, Mylan Inc. |
| ClinicalTrials.gov Identifier: | NCT00647972 History of Changes |
| Other Study ID Numbers: | OLAN-02136 |
| Study First Received: | March 30, 2008 |
| Last Updated: | November 19, 2009 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Olanzapine Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Psychotropic Drugs |
Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Serotonin Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Gastrointestinal Agents |
ClinicalTrials.gov processed this record on May 23, 2013