HealthyPhase 1NCT00871364
A Relative Bioavailability Study of 50 mg Venlafaxine Hydrochloride Tablets Under Fed Conditions
A Phase 1 study testing VENLAFAXINE TABLETS 50 mg , single dose and Effexor® Tablets equivalent to 50 mg venlafaxine in people with Healthy, run by Actavis Inc. at 1 site in Canada.
Trial summary
The purpose of this study to assess the single-dose relative bioavailability of Actavis Group hf 50 mg venlafaxine hydrochloride tablets with Wyeth Pharmaceuticals (Effexor®) 50 mg venlafaxine (as venlafaxine hydrochloride) tablets under fed conditions. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- VENLAFAXINE TABLETS 50 mg , single dose and Effexor® Tablets equivalent to 50 mg venlafaxine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2006to May 2006
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult male or female volunteers, 18-55 years of age.
- Weighing at least 60 kg for males and 52 kg for females and within 15% of their ideal weights (Table of "Desirable Weights of Adults", Metropolitan Life Insurance Company, 1983).
- Medically healthy subjects with clinically normal laboratory profiles, vital signs and ECGs.
- Females of childbearing potential were either sexually inactive (abstinent) for 14 days prior to the first dose, throughout the study and for 6 days following the last dose or were using one of the following acceptable birth control methods:
- surgically sterile (bilateral tubal ligation, hysterectomy, bilateral oophorectomy) 6 months minimum;
- IUD in place for at least 3 months;
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- barrier methods (condom, diaphragm) with spermicide for at least 14 days prior to the first dose, throughout the study and for 6 days following the last dose;
- surgical sterilization of the partner (vasectomy for 6 months minimum);
- hormonal contraceptives for at least 3 months prior to the first dose of the study and up to 6 days following the last dose. Other birth control methods may have been deemed acceptable. Postmenopausal women with amenorrhea for at least 2 years were eligible.
- Gave voluntary written informed consent to participate in the study.
Who cannot join
- History or presence of significant cardiovascular, pulmonary, hepatic, renal, haematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease.
- In addition, history or presence of:
- alcoholism or drug abuse within the past year;
- hypersensitivity or idiosyncratic reaction to venlafaxine or other selective serotonin and norepinephrine reuptake inhibitors;
- glaucoma.
- Female subjects who were pregnant or lactating.
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- Subjects who tested positive at screening for HIV, HbsAg or HCV.
- Subjects who received monoamine oxidase (MAO) inhibitors within 28 days prior to dosing.
- Subjects who used any drugs or substances known to be strong inhibitors of CYP enzymes (formerly known as P450 enzymes) within 10 days prior to the first dose.
- Subjects who used any drugs or substances known to be strong inducers of CYP enzymes (formerly known as P450 enzymes) within 28 days prior to the first dose.
- Subjects who donated 50 to 499 mL of blood within 30 days and more than 499 mL within 56 days prior to the first dose.
- Subjects who, through completion of the study, would have donated in excess of:
- 500 mL of blood in 14 days; or
- 1500 mL of blood in 180 days; or
- 2500 mL of blood in 1 year.
- Subjects whose PR interval is >200 msec at screening and prior to dosing.
- Subjects whose QTc interval is >450 msec at screening and prior to dosing.
- Subjects who completed another clinical trial within 28 days prior to the first dose.
- Subjects who were on a special diet (for whatever reason) during the 28 days prior to the first dose and throughout the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative, Randomized, Single-Dose, 2-way Crossover Bioavailability Study of Actavis Group hf 50 mg Venlafaxine Hydrochloride Tablets and Wyeth Pharmaceuticals (Effexor®) 50 mg Venlafaxine Hydrochloride Tablets
The purpose of this study to assess the single-dose relative bioavailability of Actavis Group hf 50 mg venlafaxine hydrochloride tablets with Wyeth Pharmaceuticals (Effexor®) 50 mg venlafaxine (as venlafaxine hydrochloride) tablets under fed conditions.
Read the detailed description
Study Type: Interventional Study Design: Randomized, 2-period, 2-sequence, crossover design.
Official Title: Comparative, Randomized, Single-Dose, 2-way Crossover Bioavailability Study of Actavis Group hf 50 mg Venlafaxine Hydrochloride Tablets and Wyeth Pharmaceuticals (Effexor®) 50 mg Venlafaxine Hydrochloride Tablets in Healthy Adult Volunteers under Fed Conditions.
Further study details as provided by Actavis Elizabeth LLC:
Primary Outcome Measures:
Rate and Extend of Absorption
- Conditions
- Healthy
- Being tested
- VENLAFAXINE TABLETS 50 mg , single dose, Effexor® Tablets equivalent to 50 mg venlafaxine
- Keywords
- Bioequivalence, venlafaxine, Healthy subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VENLAFAXINE TABLETS 50 mg , single doseDrug
Also called venlafaxine
A: Experimental Subjects received EMCURE PHARMACEUTICALS LTD. formulated products under fed conditions
Effexor® Tablets equivalent to 50 mg venlafaxineDrug
Also called venlafaxine
B: Active comparator Subjects received Wyeth Pharmaceuticals Inc. formulated products under fed conditions
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | VENLAFAXINE TABLETS 50 mg, single dose Receives: Drug: VENLAFAXINE TABLETS 50 mg , single dose |
| B | Active comparator | Effexor® (venlafaxine HCl) Tablets equivalent to 50 mg venlafaxine, single dose Receives: Drug: Effexor® Tablets equivalent to 50 mg venlafaxine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate and Extend of Absorption
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2009 (estimated)
- Study startApr 2006
- Primary completionMay 2006
- Study completionMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Actavis Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Gaetano Morelli,, MD, Principal investigator, MDS Pharma Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00871364
- Sponsor's protocol ID
- AA32215
- Status last verified
- Aug 2010
- First submitted
- 26 Mar 2009
- Last updated
- 16 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative, Randomized, Single-Dose, 2-way Crossover Bioavailability Study of Actavis Group hf 50 mg Venlafaxine Hydrochloride Tablets and Wyeth Pharmaceuticals (Effexor®) 50 mg Venlafaxine Hydrochloride Tablets
- ClinicalTrials.gov ID
- NCT00871364
- Acronym / sponsor ID
- AA32215
- Conditions
- Healthy
- Keywords
- Bioequivalence, venlafaxine, Healthy subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Actavis Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2006
- Primary completion
- May 2006 (actual)
- Study completion
- May 2006 (actual)
- First posted
- 30 Mar 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.
The purpose of this study to assess the single-dose relative bioavailability of Actavis Group hf 50 mg venlafaxine hydrochloride tablets with Wyeth Pharmaceuticals (Effexor®) 50 mg venlafaxine (as venlafaxine hydrochloride) tablets under fed conditions.
Detailed description
Study Type: Interventional Study Design: Randomized, 2-period, 2-sequence, crossover design.
Official Title: Comparative, Randomized, Single-Dose, 2-way Crossover Bioavailability Study of Actavis Group hf 50 mg Venlafaxine Hydrochloride Tablets and Wyeth Pharmaceuticals (Effexor®) 50 mg Venlafaxine Hydrochloride Tablets in Healthy Adult Volunteers under Fed Conditions.
Further study details as provided by Actavis Elizabeth LLC:
Primary Outcome Measures:
Rate and Extend of Absorption
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: VENLAFAXINE TABLETS 50 mg , single doseVENLAFAXINE TABLETS 50 mg, single dose |
| B | Active comparator | Drug: Effexor® Tablets equivalent to 50 mg venlafaxineEffexor® (venlafaxine HCl) Tablets equivalent to 50 mg venlafaxine, single dose |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Healthy adult male or female volunteers, 18-55 years of age.
- Weighing at least 60 kg for males and 52 kg for females and within 15% of their ideal weights (Table of "Desirable Weights of Adults", Metropolitan Life Insurance Company, 1983).
- Medically healthy subjects with clinically normal laboratory profiles, vital signs and ECGs.
- Females of childbearing potential were either sexually inactive (abstinent) for 14 days prior to the first dose, throughout the study and for 6 days following the last dose or were using one of the following acceptable birth control methods:
- Gave voluntary written informed consent to participate in the study.
Key exclusion criteria (19 listed)
- History or presence of significant cardiovascular, pulmonary, hepatic, renal, haematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease.
- In addition, history or presence of:
- Female subjects who were pregnant or lactating.
- Subjects who tested positive at screening for HIV, HbsAg or HCV.
- Subjects who received monoamine oxidase (MAO) inhibitors within 28 days prior to dosing.
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 TABLETS 50 mg , single doseAlso: venlafaxineA: Experimental Subjects received EMCURE PHARMACEUTICALS LTD. formulated products under fed conditions | Drug | A |
| Effexor® Tablets equivalent to 50 mg venlafaxineAlso: venlafaxineB: Active comparator Subjects received Wyeth Pharmaceuticals Inc. formulated products under fed conditions | Drug | B |
Primary outcome
Rate and Extend of Absorption
Time frame: 48 hours
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 16 Aug 2010.
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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.
Gaetano Morelli,, MD principal investigator
MDS Pharma Services
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 TABLETS 50 mg , single dose and Effexor® Tablets equivalent to 50 mg venlafaxine in people with Healthy, run by Actavis Inc. 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 10 inclusion and 19 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 16 Aug 2010. 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?
Rate and Extend of Absorption (time frame: 48 hours). 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 16 Aug 2010.