1. Age: 18 years and older. 
2. Sex: Male and non-pregnant, non-lactating female 
1. Women of childbearing potential must have negative serum (Beta HCG) pregnancy tests performed within 14 days prior to the start of the study and on the evening prior to each dose administration. If dosing is scheduled on Sunday or Monday, the HCG pregnancy test should be given within 48 hours prior to dosing of each study period. An additional serum (Beta HCG) pregnancy test will be performed upon completion of the study. 
2. Women of childbearing potential must practice abstinence or be using an acceptable form of contraception throughout the duration of the study. Acceptable forms of contraception include the following: 
(1) intrauterine device in place for at least 3 months prior to the start of the study and remaining in place during the study period, or (2) barrier methods containing or used in conjunction with a spermicidal agent, or (3) postmenopausal accompanied with a documented postmenopausal course of at least one year or surgical sterility (tubal ligation, oophorectomy or hysterectomy). 
3. During the course of the study, from study screen until study exit - including the washout period, women of childbearing potential must use a spermicide containing barrier method of contraception in addition to their current contraceptive device. This advice should be documented in the informed consent form. 
3. Weight: At least 60 kg (132 lbs) for man and 48 kg (106 lbs) for women and within 15% of Ideal Body Weight (IBW), as referenced by the Table of ""Desirable Weights of Adults"" Metropolitan Life Insurance Company, 1999 (See Part II ADMINISTRATIVE ASPECTS OF BIOEQUIVALENCE PROTOCOLS). 
4. All subjects should be judged normal and healthy during a pre-study medical evaluation (physical examination, laboratory evaluation, 12-lead ECG, hepatitis B and hepatitis C tests, HIV test, and urine drug screen including amphetamine, barbiturates, benzodiazepine, cannabinoid, cocaine, opiates, phencyclidine, and methadone) performed within 14 days of the initial dose of study medication. 

NCT00650312_inc_T1
Value
18 years and older
NCT00650312_inc_T2
Person
Age
NCT00650312_inc_T3
Person
Male
NCT00650312_inc_T4
Condition
pregnant
NCT00650312_inc_T5
Negation
non
NCT00650312_inc_T6
Negation
non
NCT00650312_inc_T7
Condition
lactating
NCT00650312_inc_T8
Person
female
NCT00650312_inc_T9
Scope
non-pregnant, non-lactating
NCT00650312_inc_T14
Measurement
Weight
NCT00650312_inc_T15
Value
At least 60 kg
NCT00650312_inc_T16
Value
At least 132 lbs
NCT00650312_inc_T17
Person
man
NCT00650312_inc_T18
Value
At least 48 kg
NCT00650312_inc_T19
Value
At least 106 lbs
NCT00650312_inc_T20
Person
women
NCT00650312_inc_T21
Scope
At least 60 kg (132 lbs) for man and 48 kg (106 lbs) for women
NCT00650312_inc_T22
Value
within 15% of Ideal Body Weight (IBW)
NCT00650312_inc_T10
Person
Women
NCT00650312_inc_T11
Condition
childbearing potential
NCT00650312_inc_T12
Value
negative
NCT00650312_inc_T13
Procedure
serum pregnancy tests
NCT00650312_inc_T23
Procedure
Beta HCG
NCT00650312_inc_T24
Temporal
within 14 days prior to the start of the study
NCT00650312_inc_T25
Reference_point
the start of the study
NCT00650312_inc_T26
Temporal
on the evening prior to each dose administration
NCT00650312_inc_T27
Reference_point
each dose administration
NCT00650312_inc_T28
Scope
Women of childbearing potential
NCT00650312_inc_T29
Scope
negative serum (Beta HCG) pregnancy tests performed within 14 days prior to the start of the study and on the evening prior to each dose administration
NCT00650312_inc_T30
Person
Women
NCT00650312_inc_T31
Condition
childbearing potential
NCT00650312_inc_T32
Procedure
abstinence
NCT00650312_inc_T33
Qualifier
acceptable form
NCT00650312_inc_T34
Procedure
contraception
NCT00650312_inc_T35
Temporal
throughout the duration of the study
NCT00650312_inc_T36
Scope
abstinence or be using an acceptable form of contraception
NCT00650312_inc_T37
Scope
Women of childbearing potential
NCT00650312_inc_T38
Device
intrauterine device
NCT00650312_inc_T39
Temporal
for at least 3 months prior to the start of the study
NCT00650312_inc_T40
Reference_point
the start of the study
NCT00650312_inc_T41
Temporal
in place during the study period
NCT00650312_inc_T42
Reference_point
the study period
NCT00650312_inc_T43
Procedure
barrier methods
NCT00650312_inc_T44
Drug
spermicidal agent
NCT00650312_inc_T45
Scope
barrier methods containing or used in conjunction with a spermicidal agent
NCT00650312_inc_T46
Condition
postmenopausal
NCT00650312_inc_T47
Temporal
at least one year
NCT00650312_inc_T48
Condition
surgical sterility
NCT00650312_inc_T49
Procedure
tubal ligation
NCT00650312_inc_T50
Procedure
oophorectomy
NCT00650312_inc_T51
Procedure
hysterectomy
NCT00650312_inc_T52
Scope
tubal ligation, oophorectomy or hysterectomy
NCT00650312_inc_T53
Scope
surgical sterility (tubal ligation, oophorectomy or hysterectomy)
NCT00650312_inc_T54
Person
women
NCT00650312_inc_T55
Condition
childbearing potential
NCT00650312_inc_T56
Procedure
spermicide containing barrier method of contraception
NCT00650312_inc_T57
Multiplier
in addition to
NCT00650312_inc_T58
Temporal
current
NCT00650312_inc_T59
Device
contraceptive device
NCT00650312_inc_T60
Scope
women of childbearing potential
NCT00650312_inc_T61
Scope
spermicide containing barrier method of contraception in addition to their current contraceptive device
NCT00650312_inc_T62
Temporal
During the course of the study
NCT00650312_inc_T63
Condition
normal
NCT00650312_inc_T64
Condition
healthy
NCT00650312_inc_T65
Procedure
pre-study medical evaluation
NCT00650312_inc_T66
Scope
normal and healthy
NCT00650312_inc_T67
Procedure
physical examination
NCT00650312_inc_T68
Procedure
laboratory evaluation
NCT00650312_inc_T69
Procedure
12-lead ECG
NCT00650312_inc_T70
Procedure
hepatitis B tests
NCT00650312_inc_T71
Procedure
hepatitis C tests
NCT00650312_inc_T72
Procedure
HIV test
NCT00650312_inc_T73
Procedure
urine drug screen
NCT00650312_inc_T74
Qualifier
amphetamine
NCT00650312_inc_T75
Qualifier
barbiturates
NCT00650312_inc_T76
Qualifier
benzodiazepine
NCT00650312_inc_T77
Qualifier
cannabinoid
NCT00650312_inc_T78
Qualifier
cocaine
NCT00650312_inc_T79
Qualifier
opiates
NCT00650312_inc_T80
Qualifier
phencyclidine
NCT00650312_inc_T81
Qualifier
methadone
NCT00650312_inc_T82
Scope
amphetamine, barbiturates, benzodiazepine, cannabinoid, cocaine, opiates, phencyclidine, and methadone
NCT00650312_inc_T83
Scope
physical examination, laboratory evaluation, 12-lead ECG, hepatitis B and hepatitis C tests, HIV test, and urine drug screen including amphetamine, barbiturates, benzodiazepine, cannabinoid, cocaine, opiates, phencyclidine, and methadone
NCT00650312_inc_T84
Temporal
within 14 days of the initial dose of study medication
NCT00650312_inc_T85
Reference_point
the initial dose of study medication