Bioavailability Study of Tranylcypromine 10mg Tablets Under Fasting Conditions
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00653393 |
Recruitment Status :
Completed
First Posted : April 4, 2008
Last Update Posted : April 4, 2008
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
To Determine the Bioavailability of Tranylcypromine | Drug: Tranylcypromine Drug: Parnate | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 39 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (Open Label) |
Official Title: | To Compare Bioavailability of Kali Tranylcypromine 10mg Tablets to That of Parnate 10 mg Tablets Under Fasting Conditions. |
Study Start Date : | October 2004 |
Actual Primary Completion Date : | November 2004 |
Actual Study Completion Date : | December 2004 |

Arm | Intervention/treatment |
---|---|
Experimental: A
Subjects received Kali product under fasting conditions
|
Drug: Tranylcypromine
Tablets, 10 mg, single-dose
Other Name: Parnate |
Active Comparator: B
Subjects received Parnate product under fasting conditions
|
Drug: Parnate
Tablets, 10 mg, single-dose
Other Name: Tranylcypromine |
- Rate and Extend of Absorption [ Time Frame: 24 hours ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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?
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00653393
United States, Florida | |
SFBC Ft. Myers, Inc | |
Ft. Myers, Florida, United States, 33901 |
Principal Investigator: | Antonio Pizzaro | SFBC Ft. Myers, Inc |
Responsible Party: | Dr. Alfred Elvin/ Director Biopharmaceutics, Par Pharmaceutical, Inc. |
ClinicalTrials.gov Identifier: | NCT00653393 |
Other Study ID Numbers: |
04-0413-001 |
First Posted: | April 4, 2008 Key Record Dates |
Last Update Posted: | April 4, 2008 |
Last Verified: | April 2008 |
bioequivalence, single- dose, fasting |
Tranylcypromine Antidepressive Agents Psychotropic Drugs Monoamine Oxidase Inhibitors Enzyme Inhibitors |
Molecular Mechanisms of Pharmacological Action Anti-Anxiety Agents Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs |