HealthyPhase 1NCT00676039
Comparison of the Pharmacokinetics of Two Generic Antidepressants and Their Respective Brand Preparations
A Phase 1 study testing Venlafaxine, Gen-Citalopram and Effexor XR in people with Healthy, run by University of Ottawa at 1 site in Canada.
Trial summary
Generic medications should be the equivalent of brand medications with the exception of their price. Before a generic medication is introduced, its bioequivalence within a window of 80 to 125% of the original has to be demonstrated. There are reports that this criterion is not always followed in post-marketed periods. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Venlafaxine, Gen-Citalopram and Effexor XR
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2007to Jul 2008
- 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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers (absence of diseases: psychiatric, physical, neurological, metabolic,...)
Who cannot join
- Psychiatric disorder
- Hepatic disease
- Renal disease
- Gastrointestinal disease
- Hematological disease
- Smokers
Show all 10Show fewer
- Physical and/or neurological disease
- Positive urine drug screen
- Abnormal blood pressure
- Abnormal urine/blood analysis (sodium, potassium, chloride, creatinine, urea, ALT, AST, total protein, glucose, and TSH)
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of Ottawa, Institute of Mental Health Research
Ottawa, Ontario, K1Z7K4
About this study
Official title: Examination of the Pharmacokinetic Properties of Two Generic Antidepressants and Their Respective Brand Preparations in Healthy Male Volunteers
Generic medications should be the equivalent of brand medications with the exception of their price. Before a generic medication is introduced, its bioequivalence within a window of 80 to 125% of the original has to be demonstrated. There are reports that this criterion is not always followed in post-marketed periods. Such investigations were triggered by the observation that some patients previously stable on original medications relapsed when switched to a presumable equivalent generic. Several factors could account for this problem. Given reports of such problems occurring with the antidepressants citalopram and venlafaxine, some pharmacokinetic properties of specific brands of generics and the originals will be examined for these two medications. Twelve healthy male volunteers will participate in this crossover study. It is anticipated that there will be significant differences emerging between the two formulations given the clinical reports of patients deteriorating when switched from the original to the generic preparations.
- Conditions
- Healthy
- Being tested
- Venlafaxine, Gen-Citalopram, Effexor XR, Celexa
- Keywords
- Therapeutic Equivalency, Human Experimentation, Bioequivalence, Brand name, Generic, Antidepressant, Healthy volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VenlafaxineDrug
NOVO-Venlafaxine XR 75 mg (NOVOPHARM, Generic)
Gen-CitalopramDrug
Gen-Citalopram 40 mg (Genpharm, Generic)
Effexor XRDrug
Effexor XR 75 mg (Wyeth Pharmaceuticals, Brand Name)
CelexaDrug
Celexa 40 mg (Lundbeck, Brand Name)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Crossover Effexor / NOVO-Venlafaxine
Examination of the bioequivalence of Effexor (Wyeth Pharmaceuticals) and NOVO-Venlafaxine (NOVOPHARM).
Both drugs will be given at the dose of 75 mg/day (one capsule per day) for 4 consecutive days. A washout period (corresponding to 10 half-life of the active metabolite desmethylvenlafaxine) will be respected after receiving each medication. Receives: Drug: Venlafaxine; Drug: Effexor XR |
| 2 | Active comparator | Crossover Celexa/Gen-citalopram
Examination of the bioequivalence of Celexa (Lundbeck, Brand Name) and Gen-Citalopram (Genpharm, Generic). Both drugs will be given at the dose of 40 mg/day (one tablet per day) for 8 consecutive days. A washout period (corresponding to 10 half-life of citalopram) will be respected after receiving each medication. Receives: Drug: Gen-Citalopram; Drug: Celexa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood levels of drugs and their metabolite (when appropriate) will be evaluated for both the generic and the brand name medication.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2008 (estimated)
- Study startNov 2007
- Primary completionJul 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ottawa
- Sponsor type
- University, hospital or other
- Investigators
- Franck Chenu, Ph.D., Study director, University of Ottawa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00676039
- Sponsor's protocol ID
- REB-2007024
- Status last verified
- Feb 2009
- First submitted
- 7 May 2008
- Last updated
- 11 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Chenu F, Batten LA, Zernig G, Ladstaetter E, Hebert C, Blier P. Comparison of pharmacokinetic profiles of brand-name and generic formulations of citalopram and venlafaxine: a crossover study. J Clin Psychiatry. 2009 Jul;70(7):958-66. doi: 10.4088/jcp.09m05315.
PubMed 19653973
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examination of the Pharmacokinetic Properties of Two Generic Antidepressants and Their Respective Brand Preparations in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT00676039
- Acronym / sponsor ID
- REB-2007024
- Conditions
- Healthy
- Keywords
- Therapeutic Equivalency, Human Experimentation, Bioequivalence, Brand name, Generic, Antidepressant, Healthy volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of OttawaUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 12 May 2008 (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.
Generic medications should be the equivalent of brand medications with the exception of their price. Before a generic medication is introduced, its bioequivalence within a window of 80 to 125% of the original has to be demonstrated. There are reports that this criterion is not always followed in post-marketed periods. Such investigations were triggered by the observation that some patients previously stable on original medications relapsed when switched to a presumable equivalent generic. Several factors could account for this problem. Given reports of such problems occurring with the antidepressants citalopram and venlafaxine, some pharmacokinetic properties of specific brands of generics and the originals will be examined for these two medications. Twelve healthy male volunteers will participate in this crossover study. It is anticipated that there will be significant differences emerging between the two formulations given the clinical reports of patients deteriorating when switched from the original to the generic preparations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Venlafaxine, Drug: Effexor XRCrossover Effexor / NOVO-Venlafaxine Examination of the bioequivalence of Effexor (Wyeth Pharmaceuticals) and NOVO-Venlafaxine (NOVOPHARM). Both drugs will be given at the dose of 75 mg/day (one capsule per day) for 4 consecutive days. A washout period (corresponding to 10 half-life of the active metabolite desmethylvenlafaxine) will be respected after receiving each medication. |
| 2 | Active comparator | Drug: Gen-Citalopram, Drug: CelexaCrossover Celexa/Gen-citalopram Examination of the bioequivalence of Celexa (Lundbeck, Brand Name) and Gen-Citalopram (Genpharm, Generic). Both drugs will be given at the dose of 40 mg/day (one tablet per day) for 8 consecutive days. A washout period (corresponding to 10 half-life of citalopram) will be respected after receiving each medication. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy volunteers (absence of diseases: psychiatric, physical, neurological, metabolic,...)
Key exclusion criteria (10 listed)
- Psychiatric disorder
- Hepatic disease
- Renal disease
- Gastrointestinal disease
- Hematological disease
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 |
|---|---|---|
| VenlafaxineNOVO-Venlafaxine XR 75 mg (NOVOPHARM, Generic) | Drug | 1 |
| Gen-CitalopramGen-Citalopram 40 mg (Genpharm, Generic) | Drug | 2 |
| Effexor XREffexor XR 75 mg (Wyeth Pharmaceuticals, Brand Name) | Drug | 1 |
| CelexaCelexa 40 mg (Lundbeck, Brand Name) | Drug | 2 |
Primary outcome
Blood levels of drugs and their metabolite (when appropriate) will be evaluated for both the generic and the brand name medication.
Time frame: 1 month
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 11 Feb 2009.
- Derived from this study: PubMed 19653973Chenu F, Batten LA, Zernig G, Ladstaetter E, Hebert C, Blier P. Comparison of pharmacokinetic profiles of brand-name and generic formulations of citalopram and venlafaxine: a crossover study. J Clin Psychiatry. 2009 Jul;70(7):958-66. doi: 10.4088/jcp.09m05315.
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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.
Franck Chenu, Ph.D. study director
University of Ottawa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Venlafaxine, Gen-Citalopram and Effexor XR in people with Healthy, run by University of Ottawa at 1 site in Canada.
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 10 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 11 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Blood levels of drugs and their metabolite (when appropriate) will be evaluated for both the generic and the brand name medication. (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00676039, which also lists 1 linked publication.
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 11 Feb 2009; AzTrials last refreshed its copy on 8 Nov 2026.