Bioavailability Study of Tranylcypromine 10mg Tablets Under Fasting Conditions - Full Text View

Sponsors and Collaborators:	Par Pharmaceutical, Inc. SFBC Ft. Myers, Inc
Information provided by:	Par Pharmaceutical, Inc.
ClinicalTrials.gov Identifier:	NCT00653393

Purpose

To compare the single-dose Bioavailability of Tranylcypromine and Parnate

Condition	Intervention	Phase
To Determine the Bioavailability of Tranylcypromine	Drug: Tranylcypromine Drug: Parnate	Phase I

Drug Information available for: Tranylcypromine Tranylcypromine sulfate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Open Label, Crossover Assignment
Official Title:	To Compare Bioavailability of Kali Tranylcypromine 10mg Tablets to That of Parnate 10 mg Tablets Under Fasting Conditions.

Further study details as provided by Par Pharmaceutical, Inc.:

Primary Outcome Measures:

Rate and Extend of Absorption [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Enrollment:	39
Study Start Date:	October 2004
Study Completion Date:	December 2004
Primary Completion Date:	November 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental Subjects received Kali product under fasting conditions	Drug: Tranylcypromine Tablets, 10 mg, single-dose
B: Active Comparator Subjects received Parnate product under fasting conditions	Drug: Parnate Tablets, 10 mg, single-dose

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00653393

Locations

United States, Florida
SFBC Ft. Myers, Inc
Ft. Myers, Florida, United States, 33901

Sponsors and Collaborators

Par Pharmaceutical, Inc.

SFBC Ft. Myers, Inc

Investigators

Principal Investigator:

Antonio Pizzaro

SFBC Ft. Myers, Inc

More Information

Responsible Party:	Par Pharmaceutical, Inc. ( Dr. Alfred Elvin/ Director Biopharmaceutics )
Study ID Numbers:	04-0413-001
Study First Received:	April 1, 2008
Last Updated:	April 3, 2008
ClinicalTrials.gov Identifier:	NCT00653393
Health Authority:	United States: Food and Drug Administration

Keywords provided by Par Pharmaceutical, Inc.:

bioequivalence, single- dose, fasting

Study placed in the following topic categories:

Tranylcypromine

Additional relevant MeSH terms:

Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Physiological Effects of Drugs
Psychotropic Drugs
Monoamine Oxidase Inhibitors

Central Nervous System Depressants
Anti-Anxiety Agents
Enzyme Inhibitors
Central Nervous System Agents
Antidepressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009