To Determine the Bioavailability of TranylcyprominePhase 1NCT00653393
Bioavailability Study of Tranylcypromine 10mg Tablets Under Fasting Conditions
A Phase 1 study testing Tranylcypromine and Parnate in people with To Determine the Bioavailability of Tranylcypromine, run by Par Pharmaceutical, Inc. at 1 site in United States.
Trial summary
To compare the single-dose Bioavailability of Tranylcypromine and Parnate Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- To Determine the Bioavailability of Tranylcypromine
- What is being tested?
- Tranylcypromine and Parnate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2004to Dec 2004
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects will be normal, healthy adult men and women who volunteer to participate.
- Is the individual healthy, nonsmoking, normal adult man or woman who volunteers to participate?
- Is s/he at least 18 years of age? Is his/her BMI between 19 and 30, exclusive?
- Is she willing to avoid pregnancy by abstaining from sexual intercourse, or by the use of barrier methods. (diaphragm, condom, foams/jellies, sponge), and IUD, or has she has been surgically sterile or post- menopausal at least six months prior to entering into the study?
- Is s/he considered reliable and capable of understanding his/her responsibility and role in the study?
- Has/s/he provided written informed consent?
- A no answer to any of the above questions indicates taht the individual is ineligible for enrollment.
Who cannot join
- Does the individual have a history of allergy or hypersensitivity to tranylcypromine?
- Does/ s/he have clinically significant laboratory abnormalities that would interface with the conduct or interpretation of the study or jeopardize his/her safety?
- Does s/he have significant history or clinical evidence of auto-immune, cardiovascular, gastrointestinal, hematopoietic, hepatic, neurological, ongoing infection, pancreatic, or renal diseases that would interface with the conduct or interpretation of the study or jeopardize his/her safety?
- Is she nursing?
- Does s/he have serious psychological illness?
- Does s/he have significant history ( within the past year) or clinical evidence of alcohol or drug abuse?
Show all 13Show fewer
- Does s/he have a positive urine drug screen or saliva alcohol screen, or a positive HIV-1 , or hepatitis B or C screen, or a positive pregnancy test?-Is s/he unable to refrain from the use of alcohol or xanthine-containing foods or beverages during periods beginning 48 hours prior to study drug administration and ending when the alst blood sample has been taken?
- Is s/he unable to refrain from the ingestion of smoked meat, cheese (except cream cheese and cottage cheese), wine and beer during periods beginning 48 hours prior to study initiation and ending seven days after the last blood sample has been taken in study period two?
- Has s/he used any prescription drug during the 14-day period prior to study initiation, or any OTC drug during the 72-hour period preceding study initiation?
- Is s/he unable to refrain from the use of all concomitant medications during the study?
- Ha s/he donated or lost blood, or participated in a clinical study which involved the with drawl of a large volume of blood (480mL or more), during the six week period preceding study initiation?
- Has s/he donated an investigational drug during the 30 day period preceding study initiation?
- A yes answer to any of the above questions indicates that the individual is ineligible for enrollment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: To Compare Bioavailability of Kali Tranylcypromine 10mg Tablets to That of Parnate 10 mg Tablets Under Fasting Conditions.
To compare the single-dose Bioavailability of Tranylcypromine and Parnate
Read the detailed description
To compare the relative Bioavailability of Tranylcypromine 10 mg tablets with that of PARNATE 10mg tablets in normal,healthy, men and women under fasting conditions
- Being tested
- Tranylcypromine, Parnate
- Keywords
- bioequivalence, single- dose, fasting
- Medical subject headings
- Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TranylcypromineDrug
Also called Parnate
Tablets, 10 mg, single-dose
ParnateDrug
Also called Tranylcypromine
Tablets, 10 mg, single-dose
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Subjects received Kali product under fasting conditions Receives: Drug: Tranylcypromine |
| B | Active comparator | Subjects received Parnate product under fasting conditions Receives: Drug: Parnate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate and Extend of Absorption
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2008 (estimated)
- Study startOct 2004
- Primary completionNov 2004
- Study completionDec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for To Determine the Bioavailability of TranylcypromineStudies 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
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Par Pharmaceutical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- SFBC Ft. Myers, Inc
- Investigators
- Antonio Pizzaro, Principal investigator, SFBC Ft. Myers, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00653393
- Sponsor's protocol ID
- 04-0413-001
- Status last verified
- Apr 2008
- First submitted
- 1 Apr 2008
- Last updated
- 4 Apr 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Compare Bioavailability of Kali Tranylcypromine 10mg Tablets to That of Parnate 10 mg Tablets Under Fasting Conditions.
- ClinicalTrials.gov ID
- NCT00653393
- Acronym / sponsor ID
- 04-0413-001
- Keywords
- bioequivalence, single- dose, fasting
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Par Pharmaceutical, Inc.Industry (pharma, biotech, devices)
- Collaborators
- SFBC Ft. Myers, Inc
- Study start
- Oct 2004
- Primary completion
- Nov 2004 (actual)
- Study completion
- Dec 2004 (actual)
- First posted
- 4 Apr 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.
To compare the single-dose Bioavailability of Tranylcypromine and Parnate
Detailed description
To compare the relative Bioavailability of Tranylcypromine 10 mg tablets with that of PARNATE 10mg tablets in normal,healthy, men and women under fasting conditions
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: TranylcypromineSubjects received Kali product under fasting conditions |
| B | Active comparator | Drug: ParnateSubjects received Parnate product under fasting conditions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects will be normal, healthy adult men and women who volunteer to participate.
- Is the individual healthy, nonsmoking, normal adult man or woman who volunteers to participate?
- Is s/he at least 18 years of age? Is his/her BMI between 19 and 30, exclusive?
- Is she willing to avoid pregnancy by abstaining from sexual intercourse, or by the use of barrier methods. (diaphragm, condom, foams/jellies, sponge), and IUD, or has she has been surgically sterile or post- menopausal at least six months prior to entering into the study?
- Is s/he considered reliable and capable of understanding his/her responsibility and role in the study?
Key exclusion criteria (13 listed)
- Does the individual have a history of allergy or hypersensitivity to tranylcypromine?
- Does/ s/he have clinically significant laboratory abnormalities that would interface with the conduct or interpretation of the study or jeopardize his/her safety?
- Does s/he have significant history or clinical evidence of auto-immune, cardiovascular, gastrointestinal, hematopoietic, hepatic, neurological, ongoing infection, pancreatic, or renal diseases that would interface with the conduct or interpretation of the study or jeopardize his/her safety?
- Is she nursing?
- Does s/he have serious psychological illness?
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 |
|---|---|---|
| TranylcypromineAlso: ParnateTablets, 10 mg, single-dose | Drug | A |
| ParnateAlso: TranylcypromineTablets, 10 mg, single-dose | Drug | B |
Primary outcome
Rate and Extend of Absorption
Time frame: 24 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 4 Apr 2008.
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.
Antonio Pizzaro principal investigator
SFBC Ft. Myers, Inc
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 Tranylcypromine and Parnate in people with To Determine the Bioavailability of Tranylcypromine, run by Par Pharmaceutical, Inc. at 1 site in United States.
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 7 inclusion and 13 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 4 Apr 2008. 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 United States. 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: 24 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 4 Apr 2008.