Bioavailability Study of Tranylcypromine 10mg Tablets Under Fasting Conditions

NCT00653393 | Completed Phase 1

• 1 other identifier: 04-0413-001
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

To compare the single-dose Bioavailability of Tranylcypromine and Parnate

Conditions

To Determine the Bioavailability of Tranylcypromine

Keywords

bioequivalence, single- dose, fasting

Outcome Measures

Primary Outcomes (1)

• Rate and Extend of Absorption

  24 hours

Study Arms (2)

A

EXPERIMENTAL

Subjects received Kali product under fasting conditions

Drug: Tranylcypromine

B

ACTIVE COMPARATOR

Subjects received Parnate product under fasting conditions

Drug: Parnate

Interventions

Tranylcypromine DRUG

Tablets, 10 mg, single-dose

Also known as: Parnate

A

Parnate DRUG

Tablets, 10 mg, single-dose

Also known as: Tranylcypromine

B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Par Pharmaceutical, Inc.: lead
• SFBC Ft. Myers, Inc: collaborator

Study Sites (1)

SFBC Ft. Myers, Inc

Fort Myers, Florida, 33901, United States

Location

MeSH Terms

Conditions

Fasting

Interventions

Tranylcypromine

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals

Study Officials

• Antonio Pizzaro

  SFBC Ft. Myers, Inc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 1, 2008
• First Posted: April 4, 2008
• Study Start: October 1, 2004
• Primary Completion: November 1, 2004
• Study Completion: December 1, 2004
• Last Updated: April 4, 2008

Record last verified: 2008-04

Locations

US (1)