HealthyPhase 1NCT01260896

Venlafaxine Hydrochloride 150 mg Extended-Release Capsules Under Fasting Conditions

A Phase 1 study testing Venlafaxine Hydrochloride and Effexor® XR in people with Healthy, run by Teva Pharmaceuticals USA at 1 site in Canada.

Completed

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

Official record

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Trial summary

The objective of this study was to compare the rate and extent of absorption of venlafaxine hydrochloride 150 mg extended-release capsules (test) versus Effexor® XR (reference) administered as 1 x 150 mg extended-release capsule under fasting conditions. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Venlafaxine Hydrochloride and Effexor® XR
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 1 siteCanada
Study dates: Sep 2002to Oct 2002
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 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Members of the community at large.
Subjects will be females and/or males, non-smokers, 18 years or age and older.
Female subjects will be post-menopausal or surgically sterilized.

Who cannot join

Clinically significant illness within 4 weeks of the administration of study medication.
Clinically significant surgery within 4 weeks prior to the administration of the study medication.
Any clinically significant abnormality found during medical screening.
Any history or presence of significant neurological, endocrinal, cardiovascular, pulmonary, hematologic, immunologic, psychiatric or metabolic disease.
History or presence of any clinically significant gastrointestinal pathology, unresolved gastrointestinal symptoms, liver or kidney disease, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of the drug.
Subjects with raised intra-ocular pressure or at risk of acute narrow angle glaucoma.

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Subjects predisposed to bleeding of the skin and mucous membrane.
Subjects with a history of seizures.
Any reason which, in the opinion of the medical sub-investigator, would prevent the subject from participating in the study.
Abnormal laboratory tests judged clinically significant.
Positive urine drug screen at screening.
Positive testing for hepatitis B, hepatitis C, or HIV at screening.
ECG abnormalities (clinically significant) or vital sign abnormalities at screening.
Subjects with BMI > 30.0.
History of significant alcohol abuse within six months of the screening visit or any indication of the regular use of more than fourteen units of alcohol per week (1 unit = 150 mL of wine, or 360 mL of beer, or 45 mL of alcohol 40%).
History of drug abuse or use of illegal drugs: use of soft drugs (such as marijuana) within 3 months of the screening visit or hard drugs (such as cocaine, PCP, and crack) within 1 year of the screening visit.
Any food allergy, intolerance, restriction, or special diet that, in the opinion of the medical sub-investigator, contraindicates the subject's participation in the study.
History of allergic reaction to venlafaxine hydrochloride.
History of allergic reaction to heparin.
Use of any drugs known to induce or inhibit hepatic drug metabolism, use of any investigational drug, or participation in an investigational study within 30 days prior to administration of the study medication.
Use of prescription medication within 14 days prior to administration of study medication or over-the-counter products within 7 days prior to administration of study medication, except for topical products without systemic absorption.
Subjects who have had a depot injection or an implant of any drug 3 months prior to the administration of study medication.
Donation of plasma (500 mL) within 7 days. Donation or loss of whole blood prior to administration of the study medication as follows:
less than 300 mL of whole blood within 30 days, or
300 mL to 500 mL of whole blood within 45 days, or
more than 500 mL of whole blood within 56 days.
Positive alcohol breath test at screening.
Subjects who have used tobacco in any form within the 90 days preceding study drug administration.
Subjects who have consumed food or beverages containing grapefruit within 7 days prior to administration of the study medication.
Intolerance to venipunctures.
Additional exclusion criteria for females only:
Breast-feeding subjects.
Positive urine pregnancy test at screening.

Trial locations and contacts

1 site in 1 country.

Canada1 site

Anapharm Inc.
Sainte-Foy, Quebec, G1V 2K8

Other trials in Canada

About this study

Official title: Randomized, 2-way Crossover, Bioequivalence Study of Venlafaxine Hydrochloride 150 mg Extended-Release Capsules and Effexor® XR 150 mg Extended-Release Capsules Administered as 1 x 150 mg Extended-Release Capsule in Healthy Subjects Under Fasting Conditions.

Conditions: Healthy
Being tested: Venlafaxine Hydrochloride, Effexor® XR
Keywords: Bioequivalence, Healthy Subjects

What participants receive

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

Venlafaxine HydrochlorideDrug
150 mg Extended-Release Capsule
Effexor® XRDrug
Also called Velafaxine Hydrochloride (generic name)
150 mg Extended-Release Capsule

Study groups in NCT01260896
Study group	Role	What they receive
Investigational Test Product	Experimental	150 mg Venlafaxine Hydrochloride Extended-Release Capsules Receives: Drug: Venlafaxine Hydrochloride
Reference Listed Drug	Active comparator	150 mg Effexor® XR Extended-Release Capsules Receives: Drug: Effexor® XR

What is being measured

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

Cmax of Venlafaxine.
Bioequivalence based on Venlafaxine Cmax (maximum observed concentration of drug substance in plasma).
Measured: Blood samples collected over a 36 hour period.
AUC0-t of Venlafaxine.
Bioequivalence based on Venlafaxine AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration).
Measured: Blood samples collected over a 36 hour period.
AUC0-inf of Venlafaxine.
Bioequivalence based on Venlafaxine AUC0-inf (area under the concentration-time curve from time zero to infinity).
Measured: Blood samples collected over a 36 hour period.

Secondary outcomes (3)

Cmax of O-Desmethylvenlafaxine.
Informational comparison of Cmax values for the metabolite O-Desmethylvenlafaxine.
Measured: Blood samples collected over a 36 hour period.
AUC0-t of O-Desmethylvenlafaxine.
Informational comparison of AUC0-t values for the metabolite O-Desmethylvenlafaxine.
Measured: Blood samples collected over a 36 hour period.
AUC0-inf of O-Desmethylvenlafaxine.
Informational comparison of AUC0-inf values for the metabolite O-Desmethylvenlafaxine.
Measured: Blood samples collected over a 36 hour period.

Timeline

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

Sep 2002Oct 2002

First posted15 Dec 2010 (estimated)
Study startSep 2002
Primary completionOct 2002
Study completionOct 2002

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 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
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01260896
Sponsor's protocol ID: 02204
Status last verified: Jan 2011
First submitted: 14 Dec 2010
Last updated: 21 Feb 2011
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

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Study at a glance

From the registry record, last updated by the sponsor on 21 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized, 2-way Crossover, Bioequivalence Study of Venlafaxine Hydrochloride 150 mg Extended-Release Capsules and Effexor® XR 150 mg Extended-Release Capsules Administered as 1 x 150 mg Extended-Release Capsule in Healthy Subjects Under Fasting Conditions.
ClinicalTrials.gov ID: NCT01260896
Acronym / sponsor ID: 02204
Conditions: Healthy
Keywords: Bioequivalence, Healthy Subjects
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Teva Pharmaceuticals USAIndustry (pharma, biotech, devices)
Study start: Sep 2002
Primary completion: Oct 2002 (actual)
Study completion: Oct 2002 (actual)
First posted: 15 Dec 2010 (estimated)
Results: Posted 21 Feb 2011

Clinical summary

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

Study design

Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Investigational Test Product	Experimental	Drug: Venlafaxine Hydrochloride150 mg Venlafaxine Hydrochloride Extended-Release Capsules
Reference Listed Drug	Active comparator	Drug: Effexor® XR150 mg Effexor® XR Extended-Release Capsules

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Members of the community at large.
Subjects will be females and/or males, non-smokers, 18 years or age and older.
Female subjects will be post-menopausal or surgically sterilized.

Key exclusion criteria (33 listed)

Clinically significant illness within 4 weeks of the administration of study medication.
Clinically significant surgery within 4 weeks prior to the administration of the study medication.
Any clinically significant abnormality found during medical screening.
Any history or presence of significant neurological, endocrinal, cardiovascular, pulmonary, hematologic, immunologic, psychiatric or metabolic disease.
History or presence of any clinically significant gastrointestinal pathology, unresolved gastrointestinal symptoms, liver or kidney disease, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of the drug.

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
Venlafaxine Hydrochloride150 mg Extended-Release Capsule	Drug	Investigational Test Product
Effexor® XRAlso: Velafaxine Hydrochloride (generic name)150 mg Extended-Release Capsule	Drug	Reference Listed Drug

Primary outcome

Cmax of Venlafaxine.
Time frame: Blood samples collected over a 36 hour period.
Bioequivalence based on Venlafaxine Cmax (maximum observed concentration of drug substance in plasma).
AUC0-t of Venlafaxine.
Time frame: Blood samples collected over a 36 hour period.
Bioequivalence based on Venlafaxine AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration).
AUC0-inf of Venlafaxine.
Time frame: Blood samples collected over a 36 hour period.
Bioequivalence based on Venlafaxine AUC0-inf (area under the concentration-time curve from time zero to infinity).

3 secondary outcomes

Cmax of O-Desmethylvenlafaxine.
Time frame: Blood samples collected over a 36 hour period.
AUC0-t of O-Desmethylvenlafaxine.
Time frame: Blood samples collected over a 36 hour period.
AUC0-inf of O-Desmethylvenlafaxine.
Time frame: Blood samples collected over a 36 hour period.

Results and safety

Results posted to the registry on 21 Feb 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Venlafaxine Hydrochloride (Test) First	12	10
Effexor® XR (Reference) First	12	12

Primary outcome: Cmax of Venlafaxine.

Time frame: Blood samples collected over a 36 hour period.. Mean (Standard Deviation). Unit: ng/mL

Measure	Venlafaxine Hydrochloride (Test) n = 22	Effexor® XR (Reference) n = 22
Value	124.75 (47.01)	117.69 (49.23)

Venlafaxine Hydrochloride (Test) vs Effexor® XR (Reference): Ratio of the T/R geometric mean x 100: 106.84 (90% CI 100.54 to 113.54)

Population analysed: All participants that completed the study had their samples analyzed.

Primary outcome: AUC0-t of Venlafaxine.

Time frame: Blood samples collected over a 36 hour period.. Mean (Standard Deviation). Unit: ng*h/mL

Measure	Venlafaxine Hydrochloride (Test) n = 22	Effexor® XR (Reference) n = 22
Value	2257.53 (1459.51)	2110.79 (1363.13)

Venlafaxine Hydrochloride (Test) vs Effexor® XR (Reference): Ratio of the T/R geometric mean x 100: 105.34 (90% CI 100.37 to 110.55)

Population analysed: All participants that completed the study had their samples analyzed.

Primary outcome: AUC0-inf of Venlafaxine.

Time frame: Blood samples collected over a 36 hour period.. Mean (Standard Deviation). Unit: ng*h/mL

Measure	Venlafaxine Hydrochloride (Test) n = 22	Effexor® XR (Reference) n = 22
Value	2811.08 (2240.01)	2700.62 (2106.47)

Venlafaxine Hydrochloride (Test) vs Effexor® XR (Reference): Ratio of the T/R geometric mean x 100: 103.12 (90% CI 97.80 to 108.73)

Population analysed: All participants that completed the study had their samples analyzed.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data was collected over the course of the study, which was approximately 3 weeks in duration.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Venlafaxine Hydrochloride (Test) First	0 of 24 (0%)	17 of 24 (70.8%)	Not reported
Effexor® XR (Reference) First	0 of 24 (0%)	14 of 24 (58.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Benoit Girard, M.D. principal investigator

Anapharm

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 Hydrochloride and Effexor® XR in people with Healthy, run by Teva Pharmaceuticals USA 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 3 inclusion and 33 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 21 Feb 2011. 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?

Yes. Results are posted in the registry (first posted 21 Feb 2011). 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?

Cmax of Venlafaxine. (time frame: Blood samples collected over a 36 hour period.). The study lists 3 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 NCT01260896.

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 21 Feb 2011.