Bioavailability Study of Tranylcypromine 10mg Tablets Under Fasting Conditions

• ClinicalTrials.gov Identifier: NCT00653393
• Recruitment Status: Completed
• First Posted: April 4, 2008
• Last Update Posted: April 4, 2008
• Sponsor: Par Pharmaceutical, Inc.
• Collaborator: SFBC Ft. Myers, Inc
• Information provided by: Par Pharmaceutical, Inc.

Study Description

Brief Summary:

To compare the single-dose Bioavailability of Tranylcypromine and Parnate

Condition or disease	Intervention/treatment	Phase
To Determine the Bioavailability of Tranylcypromine	Drug: Tranylcypromine; Drug: Parnate	Phase 1

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

• 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

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Rate and Extend of Absorption [ Time Frame: 24 hours ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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: Dr. Alfred Elvin/ Director Biopharmaceutics, Par Pharmaceutical, Inc.
• ClinicalTrials.gov Identifier: NCT00653393
• Other Study ID Numbers: 04-0413-001
• First Posted: April 4, 2008
• Last Update Posted: April 4, 2008
• Last Verified: April 2008

Keywords provided by Par Pharmaceutical, Inc.:

bioequivalence, single- dose, fasting

Additional relevant MeSH terms:

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