Bioavailability Study of Tranylcypromine 10mg Tablets Under Fasting Conditions
Bioavailability Study of Tranylcypromine 10mg Tablets Under Fasting Conditions
To compare the single-dose Bioavailability of Tranylcypromine and Parnate
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
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.