NCT00754962

Brief Summary

The objective of this study was to prove the bioequivalence of Protriptyline 10 mg tablets under fasted conditions

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at below P25 for not_applicable depression

Timeline
Completed

Started Dec 2006

Shorter than P25 for not_applicable depression

Geographic Reach
1 country

1 active site

Status
completed

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

December 1, 2006

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 17, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 18, 2008

Completed
Last Updated

January 23, 2018

Status Verified

January 1, 2018

Enrollment Period

1 month

First QC Date

September 17, 2008

Last Update Submit

January 19, 2018

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

  • Bioequivalence

    baseline, 2-period, 28 day washout

Interventions

protriptylineDRUG

10 mg tablet

Also known as: Vivactil

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Advanced Biomedical Research

Hackensack, New Jersey, 07601, United States

Location

MeSH Terms

Conditions

Depression

Interventions

Protriptyline

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

DibenzocycloheptenesBenzocycloheptenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Officials

  • Benno G Roesch, MD

    Advanced Biomedical Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 17, 2008

First Posted

September 18, 2008

Study Start

December 1, 2006

Primary Completion

January 1, 2007

Study Completion

January 1, 2007

Last Updated

January 23, 2018

Record last verified: 2018-01

Locations

US(1)