Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Cilostazol 100 mg Tablets Then Pletal® 100 mg Tablets	On the morning of Day 1 subjects received one tablet of the test formulation, Cilostazol 100 mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received one tablet of the reference formulation, Pletal® 100 mg, after an overnight fast of at least 10 hours.
Pletal® 100 mg Tablets Then Cilostazol 100 mg Tablets	On the morning of Day 1 subjects received one tablet of the reference formulation, Pletal® 100 mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received one tablet of the test formulation, Cilostazol 100 mg, after an overnight fast of at least 10 hours.

Participant Flow for 3 periods

Period 1:   First Intervention

	Cilostazol 100 mg Tablets Then Pletal® 100 mg Tablets	Pletal® 100 mg Tablets Then Cilostazol 100 mg Tablets
STARTED	16	16
COMPLETED	16	16
NOT COMPLETED	0	0

Period 2:   Washout Period of 7 Days

	Cilostazol 100 mg Tablets Then Pletal® 100 mg Tablets	Pletal® 100 mg Tablets Then Cilostazol 100 mg Tablets
STARTED	16	16
COMPLETED	14	14
NOT COMPLETED	2	2
Withdrawal by Subject	2	2

Period 3:   Second Intervention

	Cilostazol 100 mg Tablets Then Pletal® 100 mg Tablets	Pletal® 100 mg Tablets Then Cilostazol 100 mg Tablets
STARTED	14	14
COMPLETED	14	14
NOT COMPLETED	0	0

Reporting Groups

	Description
Cilostazol 100 mg Tablets and Pletal® 100 mg Tablets	All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 8, each subject received one tablet of either Cilostazol 100 mg or Pletal® 100 mg following an overnight fast of at least 10 hours.

Baseline Measures

	Cilostazol 100 mg Tablets and Pletal® 100 mg Tablets
Number of Participants   [units: participants]	32
Age   [units: participants]
<=18 years	0
Between 18 and 65 years	32
>=65 years	0
Age   [units: years] Mean ± Standard Deviation	36.09  ± 11.63
Gender   [units: participants]
Female	4
Male	28
Race (NIH/OMB)   [units: participants]
American Indian or Alaska Native	0
Asian	2
Native Hawaiian or Other Pacific Islander	0
Black or African American	21
White	8
More than one race	0
Unknown or Not Reported	1

1.  Primary:

Maximum Plasma Concentration (Cmax)   [ Time Frame: serial pharmacokinetic concentrations were drawn pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 12, 16, 24, 36 and 48 hours post-dose. ]

2.  Primary:

Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]   [ Time Frame: serial pharmacokinetic concentrations were drawn pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 12, 16, 24, 36 and 48 hours post-dose. ]

3.  Primary:

Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]   [ Time Frame: serial pharmacokinetic concentrations were drawn pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 12, 16, 24, 36 and 48 hours post-dose. ]