DepressionPhase 1NCT00914004
To Demonstrate the Relative Bioequivalency of Comparing Single 100 mg Doses Of Cord's 50 mg Desipramine HCL Tablets To Merrell Dow's 50 mg Norpramin Tablets
A Phase 1 study testing Desipramine HCl 50 mg Tablets Cord Laboratories and Norpramin 50 mg Tablets Merrell Dow Pharmaceuticals, Inc in people with Depression, run by Sandoz.
Trial summary
To demonstrate the relative bioequivalency of comparing single 100 mg doses Of Cord's 50 mg Desipramine Hcl tablets to Merrell Dow's 50 mg Norpramin tablets. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Depression
- What is being tested?
- Desipramine HCl 50 mg Tablets Cord Laboratories and Norpramin 50 mg Tablets Merrell Dow Pharmaceuticals, Inc
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.
Who cannot join
- Positive test results for HIV or hepatitis B or C.
- Treatment for drug or alcohol dependence.
About this study
Official title: A Two-Way Crossover Bioequivalency Study Comparing Single 100 mg Doses Of Cord's 50 mg Desipramine HCL Tablets To Merrell Dow's 50 mg Norpramin Tablets
To demonstrate the relative bioequivalency of comparing single 100 mg doses Of Cord's 50 mg Desipramine Hcl tablets to Merrell Dow's 50 mg Norpramin tablets.
- Conditions
- Depression
- Being tested
- Desipramine HCl 50 mg Tablets Cord Laboratories, Norpramin 50 mg Tablets Merrell Dow Pharmaceuticals, Inc
- Keywords
- Antidepressant
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Desipramine HCl 50 mg Tablets Cord LaboratoriesDrug
Norpramin 50 mg Tablets Merrell Dow Pharmaceuticals, IncDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Desipramine HCl 50 mg Tablets Cord Laboratories Receives: Drug: Desipramine HCl 50 mg Tablets Cord Laboratories |
| 2 | Active comparator | Norpramin 50 mg Tablets Merrell Dow Pharmaceuticals, Inc Receives: Drug: Norpramin 50 mg Tablets Merrell Dow Pharmaceuticals, Inc |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioequivalence based on AUC and Cmax
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sandoz
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jules Kann, Ph.D., Principal investigator, Biodecision Laboratories
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00914004
- Sponsor's protocol ID
- 8718-D
- Status last verified
- Jun 2009
- First submitted
- 2 Jun 2009
- Last updated
- 28 Mar 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two-Way Crossover Bioequivalency Study Comparing Single 100 mg Doses Of Cord's 50 mg Desipramine HCL Tablets To Merrell Dow's 50 mg Norpramin Tablets
- ClinicalTrials.gov ID
- NCT00914004
- Acronym / sponsor ID
- 8718-D
- Conditions
- Depression
- Keywords
- Antidepressant
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- SandozIndustry (pharma, biotech, devices)
- First posted
- 4 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To demonstrate the relative bioequivalency of comparing single 100 mg doses Of Cord's 50 mg Desipramine Hcl tablets to Merrell Dow's 50 mg Norpramin tablets.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Desipramine HCl 50 mg Tablets Cord LaboratoriesDesipramine HCl 50 mg Tablets Cord Laboratories |
| 2 | Active comparator | Drug: Norpramin 50 mg Tablets Merrell Dow Pharmaceuticals, IncNorpramin 50 mg Tablets Merrell Dow Pharmaceuticals, Inc |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.
Key exclusion criteria (2 listed)
- Positive test results for HIV or hepatitis B or C.
- Treatment for drug or alcohol dependence.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Desipramine HCl 50 mg Tablets Cord Laboratories | Drug | 1 |
| Norpramin 50 mg Tablets Merrell Dow Pharmaceuticals, Inc | Drug | 2 |
Primary outcome
Bioequivalence based on AUC and Cmax
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jules Kann, Ph.D. principal investigator
Biodecision Laboratories
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Desipramine HCl 50 mg Tablets Cord Laboratories and Norpramin 50 mg Tablets Merrell Dow Pharmaceuticals, Inc in people with Depression, run by Sandoz.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bioequivalence based on AUC and Cmax. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2017.