Depression - Major Depressive DisorderPhase 1NCT01190514

Phase 1 Study To Test the Bioequivalence Between Two 25 mg Tablets vs. One 50 mg Tablet Under Fast/Fed Condition and Evaluate Food Effect of Desvenlafaxine Succinate Sustained Release (DVS SR)

A Phase 1 study testing desvenlafaxine succinate sustained release in people with Depression - Major Depressive Disorder, run by Pfizer at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

To determine the bioequivalence of 2 tablets of 25 mg sustained release (SR) formulation of DVS and 1 tablet of 50 mg SR formulation of DVS under fed and fast conditions. To investigate the effect of high-fat meal on pharmacokinetics of desvenlafaxine after administration of 50 mg SR formulation of DVS. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Depression - Major Depressive Disorder
What is being tested?: desvenlafaxine succinate sustained release
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 41 participants
Where: 1 siteBelgium
Study dates: Sep 2010to Nov 2010
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy male and female subjects.

Who cannot join

Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease

Trial locations and contacts

1 site in 1 country.

Belgium1 site

Pfizer Investigational Site
Brussels, B-1070

Other trials in Belgium

About this study

Official title: Phase 1, Open-Label, Randomized, Single-Dose, 4-Treatment, 4-Period Crossover Bioequivalence Study Comparing 25 Mg and 50 Mg Formulations of DVS-233 SR and Investigate Food Effect on 50 Mg Formulations of DVS-233 SR Tablet Under Fed and Fasted Conditions

To determine the bioequivalence of 2 tablets of 25 mg sustained release (SR) formulation of DVS and 1 tablet of 50 mg SR formulation of DVS under fed and fast conditions.

To investigate the effect of high-fat meal on pharmacokinetics of desvenlafaxine after administration of 50 mg SR formulation of DVS.

Conditions: Depression - Major Depressive Disorder
Being tested: desvenlafaxine succinate sustained release
Keywords: DVS SR, healthy, Bioequivalence study

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

desvenlafaxine succinate sustained releaseDrug
Also called DVS-233 SR, Pristiq
Two tablets of 25 mg, single administration, under fed condition
desvenlafaxine succinate sustained releaseDrug
Also called DVS-233 SR, Pristiq
One tablet of 50 mg, single administration, under fed condition
desvenlafaxine succinate sustained releaseDrug
Also called DVS-233 SR, Pristiq
Two tablets of 25 mg, single administration, under fast condition
desvenlafaxine succinate sustained releaseDrug
Also called DVS-233 SR, Pristiq
One tablet of 50 mg, single administration, under fast condition

Study groups in NCT01190514
Study group	Role	What they receive
Bioequivalence and Food effect	Experimental	Not described Receives: Drug: desvenlafaxine succinate sustained release

What is being measured

The primary outcome is the main question the study is designed to answer.

Area Under the Plasma Concentration-time Profile From Time 0 to 48 Hours (AUC48)
Area under the plasma concentration versus time curve from time zero (pre-dose) to 48 hours post dose; measured as nanograms multiplied by hours divided by milliliters (ng*hr/mL).
Measured: Day 1 of Periods 1, 2, 3, and 4: pre-dose, 0 hour, and 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose
Maximum Plasma Concentration (Cmax)
Cmax measured as nanograms divided by milliliters (ng/mL).
Measured: Day 1 of Periods 1, 2, 3, and 4: pre-dose, 0 hour, and 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose

Secondary outcomes (4)

Time to Reach Maximum Observed Plasma Concentration (Tmax)
Measured: Day 1 of Periods 1, 2, 3, and 4: pre-dose, 0 hour, and 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose
Terminal Elimination Half-life (t 1/2)
Terminal elimination (plasma decay) half-life is the time measured for the plasma concentration to decrease by one half.
Measured: Day 1 of Periods 1, 2, 3, and 4: pre-dose, 0 hour, and 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose
Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf)
Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).
Measured: Day 1 of Periods 1, 2, 3, and 4: pre-dose, 0 hour, and 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose
Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Time of the Last Quantifiable Concentration (AUClast)
Measured: Day 1 of Periods 1, 2, 3, and 4: pre-dose, 0 hour, and 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2010Nov 2010

First posted27 Aug 2010 (estimated)
Study startSep 2010
Primary completionNov 2010
Study completionNov 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Depression - Major Depressive DisorderStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
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: 41 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01190514
Sponsor's protocol ID: B2061035
Status last verified: Dec 2011
First submitted: 24 Aug 2010
Last updated: 27 Jan 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2
Double-blind, Placebo-controlled Study in Adults With Major Depressive Disorder
Major Depressive Disorder (MDD)
RecruitingPhase 2
A Study to Evaluate the Safety and Efficacy of ALKS 7290 as an Adjunctive Therapy to Antidepressants in Adult Participants With Major Depressive Disorder
Major Depressive Disorder (MDD)
Recruiting
rTMS to Target Neural Connectivity and Rumination in Treatment-Resistant Depression
Depression, Treatment Resistant
Recruiting
Digital Intervention for Physical Activity
Depression - Major Depressive Disorder, Anxiety
Recruiting
Ketogenic Diet and Neuromodulation in Treatment Resistant Depression
Major Depressive Disorder (MDD), Treatment Resistant Depression (TRD)

All Depression - Major Depressive Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase 1, Open-Label, Randomized, Single-Dose, 4-Treatment, 4-Period Crossover Bioequivalence Study Comparing 25 Mg and 50 Mg Formulations of DVS-233 SR and Investigate Food Effect on 50 Mg Formulations of DVS-233 SR Tablet Under Fed and Fasted Conditions
ClinicalTrials.gov ID: NCT01190514
Acronym / sponsor ID: B2061035
Conditions: Depression - Major Depressive Disorder
Keywords: DVS SR, healthy, Bioequivalence study
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 41 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Sep 2010
Primary completion: Nov 2010 (actual)
Study completion: Nov 2010 (actual)
First posted: 27 Aug 2010 (estimated)
Results: Posted 27 Jan 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

To determine the bioequivalence of 2 tablets of 25 mg sustained release (SR) formulation of DVS and 1 tablet of 50 mg SR formulation of DVS under fed and fast conditions.

To investigate the effect of high-fat meal on pharmacokinetics of desvenlafaxine after administration of 50 mg SR formulation of DVS.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Bioequivalence and Food effect	Experimental	Drug: desvenlafaxine succinate sustained release

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (1 listed)

Healthy male and female subjects.

Key exclusion criteria (1 listed)

Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic 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
desvenlafaxine succinate sustained releaseAlso: DVS-233 SR, PristiqTwo tablets of 25 mg, single administration, under fed condition	Drug	Bioequivalence and Food effect
desvenlafaxine succinate sustained releaseAlso: DVS-233 SR, PristiqOne tablet of 50 mg, single administration, under fed condition	Drug	Bioequivalence and Food effect
desvenlafaxine succinate sustained releaseAlso: DVS-233 SR, PristiqTwo tablets of 25 mg, single administration, under fast condition	Drug	Bioequivalence and Food effect
desvenlafaxine succinate sustained releaseAlso: DVS-233 SR, PristiqOne tablet of 50 mg, single administration, under fast condition	Drug	Bioequivalence and Food effect

Primary outcome

Area Under the Plasma Concentration-time Profile From Time 0 to 48 Hours (AUC48)
Time frame: Day 1 of Periods 1, 2, 3, and 4: pre-dose, 0 hour, and 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose
Area under the plasma concentration versus time curve from time zero (pre-dose) to 48 hours post dose; measured as nanograms multiplied by hours divided by milliliters (ng*hr/mL).
Maximum Plasma Concentration (Cmax)
Time frame: Day 1 of Periods 1, 2, 3, and 4: pre-dose, 0 hour, and 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose
Cmax measured as nanograms divided by milliliters (ng/mL).

4 secondary outcomes

Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time frame: Day 1 of Periods 1, 2, 3, and 4: pre-dose, 0 hour, and 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose
Terminal Elimination Half-life (t 1/2)
Time frame: Day 1 of Periods 1, 2, 3, and 4: pre-dose, 0 hour, and 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose
Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf)
Time frame: Day 1 of Periods 1, 2, 3, and 4: pre-dose, 0 hour, and 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose
Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Time of the Last Quantifiable Concentration (AUClast)
Time frame: Day 1 of Periods 1, 2, 3, and 4: pre-dose, 0 hour, and 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose

Results and safety

Results posted to the registry on 27 Jan 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
DVS SR 25 mg*2 Fed (A) First	11	10
DVS SR 50 mg Fed (B) First	10	10
DVS SR 25 mg*2 Fasted (C) First	10	10
DVS SR 50 mg Fasted (D) First	10	10

Primary outcome: Area Under the Plasma Concentration-time Profile From Time 0 to 48 Hours (AUC48)

Time frame: Day 1 of Periods 1, 2, 3, and 4: pre-dose, 0 hour, and 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose. Mean (Standard Deviation). Unit: ng*hr/mL

Measure	DVS SR 25 mg*2 Fed n = 41	DVS SR 50 mg Fed n = 40	DVS SR 25 mg*2 Fasted n = 40	DVS SR 50 mg Fasted n = 39
Value	2948 (726.28)	2966 (836.52)	2632 (764.41)	2777 (893.35)

DVS SR 25 mg*2 Fasted vs DVS SR 50 mg Fasted: ratio (%) of adjusted geometric means: 95.56 (90% CI 86.94 to 105.04), Mixed Models Analysis
DVS SR 25 mg*2 Fed vs DVS SR 50 mg Fed: ratio (%) of adjusted geometric means: 101.31 (90% CI 97.17 to 105.64), Mixed Models Analysis
DVS SR 50 mg Fed vs DVS SR 50 mg Fasted: ratio (%) of adjusted geometric means: 108.76 (90% CI 101.10 to 117.01), Mixed Models Analysis

Population analysed: Pharmacokinetic parameter analysis (PK) population: all participants randomized and treated and had at least 1 of the PK parameters of primary interest in at least 1 treatment period. N=number of participants contributing to the mean.

Primary outcome: Maximum Plasma Concentration (Cmax)

Time frame: Day 1 of Periods 1, 2, 3, and 4: pre-dose, 0 hour, and 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose. Mean (Standard Deviation). Unit: ng/mL

Measure	DVS SR 25 mg*2 Fed n = 41	DVS SR 50 mg Fed n = 40	DVS SR 25 mg*2 Fasted n = 40	DVS SR 50 mg Fasted n = 39
Value	130.6 (29.711)	131.0 (36.308)	107.3 (26.773)	112.1 (28.510)

DVS SR 25 mg*2 Fasted vs DVS SR 50 mg Fasted: Ratio (%) of adjusted geometric means: 95.10 (90% CI 89.37 to 101.20), Mixed Models Analysis
DVS SR 25 mg*2 Fed vs DVS SR 50 mg Fed: Ratio (%) of adjusted geometric means: 101.30 (90% CI 94.66 to 108.40), Mixed Models Analysis
DVS SR 50 mg Fed vs DVS SR 50 mg Fasted: ratio (%) of adjusted geometric means: 115.54 (90% CI 108.59 to 122.94), Mixed Models Analysis

Population analysed: PK population; N=number of participants contributing to the mean.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Events collected from the time of informed consent up to 28 days after last dose of study treatment.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
DVS SR 25 mg*2 Fed	0 of 41 (0%)	19 of 41 (46.3%)	Not reported
DVS SR 50 mg Fed	0 of 40 (0%)	19 of 40 (47.5%)	Not reported
DVS SR 25 mg*2 Fasted	0 of 40 (0%)	19 of 40 (47.5%)	Not reported
DVS SR 50 mg Fasted	0 of 39 (0%)	16 of 39 (41%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

Related trials for Depression - Major Depressive Disorder

RecruitingPhase 2
Double-blind, Placebo-controlled Study in Adults With Major Depressive Disorder
Major Depressive Disorder (MDD)
RecruitingPhase 2
A Study to Evaluate the Safety and Efficacy of ALKS 7290 as an Adjunctive Therapy to Antidepressants in Adult Participants With Major Depressive Disorder
Major Depressive Disorder (MDD)
Recruiting
rTMS to Target Neural Connectivity and Rumination in Treatment-Resistant Depression
Depression, Treatment Resistant
Recruiting
Digital Intervention for Physical Activity
Depression - Major Depressive Disorder, Anxiety
Recruiting
Ketogenic Diet and Neuromodulation in Treatment Resistant Depression
Major Depressive Disorder (MDD), Treatment Resistant Depression (TRD)

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.

Pfizer CT.gov Call Center study director

Pfizer

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 desvenlafaxine succinate sustained release in people with Depression - Major Depressive Disorder, run by Pfizer at 1 site in Belgium.

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 1 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 27 Jan 2012. 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 Belgium. 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?

Yes. Results are posted in the registry (first posted 27 Jan 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Area Under the Plasma Concentration-time Profile From Time 0 to 48 Hours (AUC48) (time frame: Day 1 of Periods 1, 2, 3, and 4: pre-dose, 0 hour, and 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose). The study lists 2 primary outcomes in all. 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 NCT01190514.

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 27 Jan 2012.