Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Thirty-two healthy adult male and female volunteers from the community-at-large were enrolled.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
Cilostazol 50 mg Tablets Then Pletal® 50 mg Tablets	On the morning of Day 1 subjects received two tablets of the test formulation, Cilostazol 50 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 two tablets of the reference formulation, Pletal® 50 mg, after an overnight fast of at least 10 hours.
Pletal® 50 mg Tablets Then Cilostazol 50 mg Tablets	On the morning of Day 1 subjects received two tablets of the reference formulation, Pletal® 50 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 two tablets of the test formulation, Cilostazol 50 mg, after an overnight fast of at least 10 hours.

Participant Flow for 3 periods

Period 1:   First Intervention

	Cilostazol 50 mg Tablets Then Pletal® 50 mg Tablets	Pletal® 50 mg Tablets Then Cilostazol 50 mg Tablets
STARTED	16	16
COMPLETED	16	16
NOT COMPLETED	0	0

Period 2:   Washout Period of 7 Days

	Cilostazol 50 mg Tablets Then Pletal® 50 mg Tablets	Pletal® 50 mg Tablets Then Cilostazol 50 mg Tablets
STARTED	16	16
COMPLETED	14	15
NOT COMPLETED	2	1
Protocol Violation	2	0
Withdrawal by Subject	0	1

Period 3:   Second Intervention

	Cilostazol 50 mg Tablets Then Pletal® 50 mg Tablets	Pletal® 50 mg Tablets Then Cilostazol 50 mg Tablets
STARTED	14	15
COMPLETED	14	15
NOT COMPLETED	0	0

Reporting Groups

	Description
Cilostazol 50 mg Tablets and Pletal® 50 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 two tablets of either Cilostazol 50 mg or Pletal® 50 mg following an overnight fast of at least 10 hours.

Baseline Measures

	Cilostazol 50 mg Tablets and Pletal® 50 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	32.25  ± 11.98
Gender   [units: participants]
Female	14
Male	18
Race (NIH/OMB)   [units: participants]
American Indian or Alaska Native	0
Asian	1
Native Hawaiian or Other Pacific Islander	0
Black or African American	26
White	5
More than one race	0
Unknown or Not Reported	0

1.  Primary:

Maximum Plasma Concentration (Cmax)   [ Time Frame: serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 12, 16, 24, 36 and 48 hours after drug administration. ]

2.  Primary:

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

3.  Primary:

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