To Demonstrate the Relative Bioequivalency of Cord's 100 mg Desipramine HCL Tablets To Merrell Dow's 100 mg Norpramin Tablets
Sponsor
Sandoz (Industry)
Overall Status
Completed
CT.gov ID
NCT00913809
Collaborator
(none)
36
2
Study Details
Study Description
Brief Summary
To demonstrate the relative bioequivalency of Cord's 100 mg Desipramine HCl tablets to Merrell Dow's 100 mg Norpramin tablets.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
36 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Two-Way Single Dose Crossover Bioequivalency of Cord's 100 mg Desipramine HCL Tablets To Merrell Dow's 100 mg Norpramin Tablets
Study Start Date
:
Dec 1, 1987
Actual Primary Completion Date
:
Dec 1, 1987
Actual Study Completion Date
:
Dec 1, 1987
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 1 Desipramine HCL 100 mg Tablets Cord Laboratories |
Drug: Desipramine HCL 100 mg Tablets Cord Laboratories
|
| Active Comparator: 2 Norpramin 100 mg Tablets Merrell Dow Pharmaceuticals, Inc |
Drug: Norpramin 100 mg Tablets Merrell Dow Pharmaceuticals, Inc
|
Outcome Measures
Primary Outcome Measures
- Bioequivalence based on AUC and Cmax [24 days]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 50 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
- No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.
Exclusion Criteria:
-
Positive test results for HIV or hepatitis B or C.
-
Treatment for drug or alcohol dependence.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Sandoz
Investigators
- Principal Investigator: Jules Kann, Ph.D., Biodecision Laboratories
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00913809
Other Study ID Numbers:
- 870609-D
First Posted:
Jun 4, 2009
Last Update Posted:
Mar 28, 2017
Last Verified:
Jun 1, 2009