Bioequivalency Study of Protriptyline 10 mg Tablets Under Fasted Conditions
Sponsor
Roxane Laboratories (Industry)
Overall Status
Completed
CT.gov ID
NCT00754962
Collaborator
(none)
38
1
1
37.3
Study Details
Study Description
Brief Summary
The objective of this study was to prove the bioequivalence of Protriptyline 10 mg tablets under fasted conditions
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| N/A |
Study Design
Study Type:
Interventional
Actual Enrollment
:
38 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Single Dose, 2-Period, 2-way Crossover Bioequivalency Study of Protriptyline Tablets 10 mg Under Fasted Conditions
Study Start Date
:
Dec 1, 2006
Actual Primary Completion Date
:
Jan 1, 2007
Actual Study Completion Date
:
Jan 1, 2007
Outcome Measures
Primary Outcome Measures
- Bioequivalence [baseline, 2-period, 28 day washout]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 45 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
- No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening
Exclusion Criteria:
-
Positive test for HIV, Hepatitis B, or Hepatitis C.
-
Treatment with known enzyme altering drugs.
-
History of allergic or adverse response to Protriptyline or any comparable or similar product.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Advanced Biomedical Research | Hackensack | New Jersey | United States | 07601 |
Sponsors and Collaborators
- Roxane Laboratories
Investigators
- Principal Investigator: Benno G Roesch, MD, Advanced Biomedical Research
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00754962
Other Study ID Numbers:
- PROT-T10-PVFS-1
First Posted:
Sep 18, 2008
Last Update Posted:
Jan 23, 2018
Last Verified:
Jan 1, 2018