Study Stopped
during Period 1 due to numerous orthostatic AEs that occurred. Subsequently, RLD was reduced to 5 mg due to safety concerns.
Fasting Study of Olanzapine Tablets 20 mg and Zyprexa® Tablets 20 mg
Single-Dose Fasting In Vivo Bioequivalence Study of Olanzapine Tablets (20 mg; Mylan) and Zyprexa® Tablets (20 mg; Eli Lilly) in Healthy Volunteers
1 other identifier
interventional
32
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2003
CompletedFirst Submitted
Initial submission to the registry
March 30, 2008
CompletedFirst Posted
Study publicly available on registry
April 1, 2008
CompletedApril 23, 2024
April 1, 2024
Same day
March 30, 2008
April 22, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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.
blood collections through 144 hours
Study Arms (2)
1
EXPERIMENTALOlanzapine Tablets 20 mg
2
ACTIVE COMPARATORZyprexa® Tablets 20 mg
Interventions
Eligibility Criteria
You may qualify if:
- healthy, adult subjects, 18 years and older
- able to swallow medication
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kendle International Inc.
Morgantown, West Virginia, 26505, United States
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Thomas S Clark, M.D.
Kendle International Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 30, 2008
First Posted
April 1, 2008
Study Start
May 1, 2003
Primary Completion
May 1, 2003
Last Updated
April 23, 2024
Record last verified: 2024-04