NCT00946764

Brief Summary

To demonstrate the relative bioavailability of Sandoz Inc. and Tyco Healthcare (Tofranil) 50 mg imipramine hydrochloride tablets in healthy adult volunteers under fasting conditions.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P50-P75 for phase_1 depression

Timeline
Completed

Started Jul 2005

Shorter than P25 for phase_1 depression

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

July 1, 2005

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

July 24, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 27, 2009

Completed
Last Updated

March 28, 2017

Status Verified

July 1, 2009

Enrollment Period

2 months

First QC Date

July 24, 2009

Last Update Submit

March 27, 2017

Conditions

Depression

Keywords

Antidepressant

Outcome Measures

Primary Outcomes (1)

  • Bioequivalence based on AUC and Cmax

    41 days

Study Arms (2)

1

EXPERIMENTAL

Imipramine Hydrochloride 50 mg Tablets (Sandoz Inc.)

Drug: Imipramine Hydrochloride 50 mg Tablets (Sandoz Inc.)

2

ACTIVE COMPARATOR

Tofranil Imipramine Hydrochloride 50 mg Tablets (Tyco Healthcare)

Drug: Tofranil Imipramine Hydrochloride 50 mg Tablets (Tyco Healthcare)

Interventions

Imipramine Hydrochloride 50 mg Tablets (Sandoz Inc.)DRUG
1
Tofranil Imipramine Hydrochloride 50 mg Tablets (Tyco Healthcare)DRUG
2

Eligibility Criteria

Age19 Years - 54 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

You may not qualify if:

  • Positive test results for HIV or hepatitis B or C.
  • Treatment for drug or alcohol dependence.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Depression

Interventions

Imipramine

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

DibenzazepinesHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Gaetano Morelli, M.D.

    MDS Pharma Services

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 24, 2009

First Posted

July 27, 2009

Study Start

July 1, 2005

Primary Completion

September 1, 2005

Study Completion

September 1, 2005

Last Updated

March 28, 2017

Record last verified: 2009-07