HealthyPhase 1NCT01512459
Bioavailability Study of Venlafaxine MR Capsules 150 mg Under Fed Conditions
A Phase 1 study testing Venlafaxine in people with Healthy, run by Dr. Reddy's Laboratories Limited at 1 site in India.
Trial summary
The objective of this study was to compare the relative bioavailability of Venlafaxine MR Capsules 150 mg with Effexor XR Capsules 150 mg under Fed conditions in healthy adult human subjects. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Venlafaxine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteIndia
- Study dates
- May 2006to Jun 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects must fulfill all of the following criteria to be considered for inclusion into this study:
- Subjects who will provide written informed consent.
- Subjects must be healthy human beings within 18-45 years of age (inclusive) weighing at least 50 kg.
- Having a Body mass Index (BMI) between 18.5 and 24.9 (both inclusive), calculated as weight in Kg/height in m2
- Subjects must be of normal health as determined by medical history and physical examination performed within 21days prior to the commencement of the study.
- Subjects whose screening laboratory values are within normal limits or considered by the physician/investigator to be of no clinical significance.
- Have normal ECG, X-ray and vital signs.
- Availability of the subject for the entire study period and willingness to adhere to the protocol requirements as evidence by written informed consent.
Who cannot join
- Subjects incapable of understanding the informed consent.
- Subjects who have:
- Systolic blood pressure less than 90 mm of Hg and more than 140 .mm of Hg
- Diastolic blood pressure less than 60 mm of Hg and more than 94 mm of Hg. Minor deviations (2-4 mm of Hg) at check-in may be acceptable at the discretion of the physician/investigator.
- Pulse rate below 50/min and above 100/min.
- History of hypersensitivity or idiosyncratic reaction to Venlafaxine or any other related drugs.
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- Any evidence of impairment of renal, hepatic, cardiac, lung or gastrointestinal .function.
- Consumption of grapefruit for the past ten days prior to the dosing day until the completion of the study.
- Regular smoker who has a habit of smoking more than nine cigarettes per day and has difficulty in abstaining from smoking from 48 hours before dosing and until the completion of the study.
- Subjects who have taken over the counter or prescribed medications for during the last 7 days from the date of study.
- Subjects who have taken enzyme modifying drugs or any systemic medication within the past 30 days prior to start of clinical study
- History of any psychiatric illness, which may impair the ability to provide written, informed consent.
- Subjects with clinically significant abnormal values of laboratory parameters.
- Subjects who have participated in any other clinical investigation using experimental drug or had bled more than 330 mL in the past 90 days before the date of start of study.
- Subjects with positive screen for drugs of abuse and alcohol.
- Any subject in whom Venlafaxine is contraindicated for medical reasons.
- Any subject with recent history of surgery
- A history of difficulty in donating blood.
- A positive test result for HIV antibody and/or syphilis
- A recent history of alcoholism (< 2 years) or of moderate (180 ml/day) alcohol use, or consumption of alcohol within 48 hr prior to receiving Investigational Product.
- Female subjects who are pregnant or who are able (women with child bearing potential) to become pregnant during the study will not be allowed to participate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label, Balanced, Randomized, Two-treatment, Two-sequence Two-period, Single Dose Sprinkled on Apple Sauce, Crossover and Relative Bioavailability Study in Healthy Adult, Human Subjects Under Fed Conditions
The objective of this study was to compare the relative bioavailability of Venlafaxine MR Capsules 150 mg with Effexor XR Capsules 150 mg under Fed conditions in healthy adult human subjects.
Read the detailed description
An open labeL balanced, randomized, two-treatment. two-period, two-sequence, single dose,crossover, evaluation of relative bioavailability of Venlafaxine 150 mg (as the HCl salt)MR capsules of Dr. Reddy's comparing with that of Effexor XR (containing Venlafaxine 150 mg (as the HCl salt)capsules of wyeth Laboratories, Philadelphia, PA, USA in healthy human subjects under fed conditions.
- Conditions
- Healthy
- Being tested
- Venlafaxine
- Keywords
- Bioavailability, Venlafaxine, two way crossover
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VenlafaxineDrug
Also called Effexor XR
Venlafaxine MR Capsules 150 mg
| Study group | Role | What they receive |
|---|---|---|
| Venlafaxine MR Capsules 150 | Experimental | Venlafaxine MR Capsules 150 of Dr.Reddy's Laboratories Limited Receives: Drug: Venlafaxine |
| Effexor XR 150 mg Capsules | Active comparator | Effexor XR 150 mg Capsules of Wyeth Laboratories Philadelphia, PA, USA Receives: Drug: Venlafaxine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under Curve (AUC)
Measured: predose, 1.00, 3.00, 4.00, 5.00, 6.00, 7.00, 8.00, 9.00, 10.00, 12.00, 14.00, 24.00, 36.00, 48.00 and 72.00 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2012 (estimated)
- Study startMay 2006
- Primary completionMay 2006
- Study completionJun 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Reddy's Laboratories Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mohanlal Siva Prasad Sayana, Dr., Principal investigator, Bioserve Clinical Research (P) Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01512459
- Sponsor's protocol ID
- 610/06
- Status last verified
- Jan 2012
- First submitted
- 10 Jan 2012
- Last updated
- 19 Jan 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Balanced, Randomized, Two-treatment, Two-sequence Two-period, Single Dose Sprinkled on Apple Sauce, Crossover and Relative Bioavailability Study in Healthy Adult, Human Subjects Under Fed Conditions
- ClinicalTrials.gov ID
- NCT01512459
- Acronym / sponsor ID
- 610/06
- Conditions
- Healthy
- Keywords
- Bioavailability, Venlafaxine, two way crossover
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Dr. Reddy's Laboratories LimitedIndustry (pharma, biotech, devices)
- Study start
- May 2006
- Primary completion
- May 2006 (actual)
- Study completion
- Jun 2006 (actual)
- First posted
- 19 Jan 2012 (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 objective of this study was to compare the relative bioavailability of Venlafaxine MR Capsules 150 mg with Effexor XR Capsules 150 mg under Fed conditions in healthy adult human subjects.
Detailed description
An open labeL balanced, randomized, two-treatment. two-period, two-sequence, single dose,crossover, evaluation of relative bioavailability of Venlafaxine 150 mg (as the HCl salt)MR capsules of Dr. Reddy's comparing with that of Effexor XR (containing Venlafaxine 150 mg (as the HCl salt)capsules of wyeth Laboratories, Philadelphia, PA, USA in healthy human subjects under fed conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Venlafaxine MR Capsules 150 | Experimental | Drug: VenlafaxineVenlafaxine MR Capsules 150 of Dr.Reddy's Laboratories Limited |
| Effexor XR 150 mg Capsules | Active comparator | Drug: VenlafaxineEffexor XR 150 mg Capsules of Wyeth Laboratories Philadelphia, PA, USA |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Subjects must fulfill all of the following criteria to be considered for inclusion into this study:
- Subjects who will provide written informed consent.
- Subjects must be healthy human beings within 18-45 years of age (inclusive) weighing at least 50 kg.
- Having a Body mass Index (BMI) between 18.5 and 24.9 (both inclusive), calculated as weight in Kg/height in m2
- Subjects must be of normal health as determined by medical history and physical examination performed within 21days prior to the commencement of the study.
Key exclusion criteria (21 listed)
- Subjects incapable of understanding the informed consent.
- Subjects who have:
- History of hypersensitivity or idiosyncratic reaction to Venlafaxine or any other related drugs.
- Any evidence of impairment of renal, hepatic, cardiac, lung or gastrointestinal .function.
- Consumption of grapefruit for the past ten days prior to the dosing day until the completion of the study.
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 |
|---|---|---|
| VenlafaxineAlso: Effexor XRVenlafaxine MR Capsules 150 mg | Drug | Effexor XR 150 mg Capsules, Venlafaxine MR Capsules 150 |
Primary outcome
Area Under Curve (AUC)
Time frame: predose, 1.00, 3.00, 4.00, 5.00, 6.00, 7.00, 8.00, 9.00, 10.00, 12.00, 14.00, 24.00, 36.00, 48.00 and 72.00 hours post-dose
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 19 Jan 2012.
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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.
Mohanlal Siva Prasad Sayana, Dr. principal investigator
Bioserve Clinical Research (P) Ltd
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 in people with Healthy, run by Dr. Reddy's Laboratories Limited at 1 site in India.
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 8 inclusion and 21 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 19 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 India. 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?
Area Under Curve (AUC) (time frame: predose, 1.00, 3.00, 4.00, 5.00, 6.00, 7.00, 8.00, 9.00, 10.00, 12.00, 14.00, 24.00, 36.00, 48.00 and 72.00 hours post-dose). 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 19 Jan 2012.