A Mono-center Study in Healthy Volunteers on the Comparative Bioavailability of Pletal 100 mg Tablets and a New Pletal 100 mg Orodispersible Tablet (ODT), This Latter in Fasting Conditions With and Without Water and Under Fed Conditions
Primary Purpose
Intermittent Claudication
Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
Cilostazol
Sponsored by
About this trial
This is an interventional treatment trial for Intermittent Claudication
Eligibility Criteria
Inclusion Criteria:
- healthy male and female subjects of Caucasian race
- able to read, to write and to fully understand German language
- having given voluntary written informed consent before first invasive screening examination procedure
- aged 18 to 45 years, inclusive
- BMI of 18 - 28 kg/m2
- good health as determined by medical history, physical examination, vital signs, electrocardiogram (ECG, serum/urine biochemistry and hematology)
Exclusion Criteria:
- clinically relevant allergy (except for untreated, asymptomatic, seasonal allergies at time of dosing) drug hypersensitivity
- known hypersensitivity to one of the IMP substances
- severe digestive disorder or surgery of the digestive tract (except for appen¬dectomy)
- clinically relevant renal disorders (albuminuria, chronic infections)
- clinically relevant hepatic disorders
- clinically relevant respiratory disorders
- clinically relevant cardiovascular disorders, especially any history of ventricular tachycardia, ventricular fibrillation or multifocal ventricular ectopics, or a history of additional risk factors for torsades de pointes (TdP) (e.g. heart failure, hypokalemia, congenital long QT-syndrome)
- diabetes mellitus and thyroid dysfunction or other endocrine disorders
- malignancy
- substance abuse or addiction (alcohol, illicit drugs) in the past 3 years
- neurologic or psychiatric illness
- known predisposition to bleeding (e.g. active peptic ulceration, recent (within 6 month) haemorrhagic stroke, surgery within the previous three months, proliferative diabetic retinopathy, poorly controlled hypertension)
Sites / Locations
- AAIPharma Deutschland GmbH & Co. KG
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Experimental
Experimental
Active Comparator
Arm Label
A
B
C
D
Arm Description
Intake of Pletal 100 mg tablets dose together with 200 ml water
Intake of Pletal 100 mg ODT dose without water
Intake of Pletal 100 mg ODT dose together with 200 ml water
Intake of Pletal 100 mg ODT dose without water
Outcomes
Primary Outcome Measures
Area under the curve, maximal concentration (Cmax)
Secondary Outcome Measures
Time of maximum (tmax), Vss/f, CL/f)
Full Information
NCT ID
NCT00773630
First Posted
October 15, 2008
Last Updated
September 8, 2011
Sponsor
Otsuka Frankfurt Research Institute GmbH
1. Study Identification
Unique Protocol Identification Number
NCT00773630
Brief Title
A Mono-center Study in Healthy Volunteers on the Comparative Bioavailability of Pletal 100 mg Tablets and a New Pletal 100 mg Orodispersible Tablet (ODT), This Latter in Fasting Conditions With and Without Water and Under Fed Conditions
Study Type
Interventional
2. Study Status
Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Otsuka Frankfurt Research Institute GmbH
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The primary objective of this trial is to test whether Pletal ODT administered without water can be considered bioequivalent to Pletal administered with 200 ml water (both treatments being administered after fasting and at least 30 minutes prior to receiving a light breakfast) based on the standard pharmacokinetic variables.
The secondary objective is to assess the effect of water and the effect of food on the administration of Pletal ODT based on standard pharmacokinetic variables.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intermittent Claudication
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Active Comparator
Arm Description
Intake of Pletal 100 mg tablets dose together with 200 ml water
Arm Title
B
Arm Type
Experimental
Arm Description
Intake of Pletal 100 mg ODT dose without water
Arm Title
C
Arm Type
Experimental
Arm Description
Intake of Pletal 100 mg ODT dose together with 200 ml water
Arm Title
D
Arm Type
Active Comparator
Arm Description
Intake of Pletal 100 mg ODT dose without water
Intervention Type
Drug
Intervention Name(s)
Cilostazol
Intervention Description
100 mg Cilostazol
Primary Outcome Measure Information:
Title
Area under the curve, maximal concentration (Cmax)
Time Frame
1-2 months
Secondary Outcome Measure Information:
Title
Time of maximum (tmax), Vss/f, CL/f)
Time Frame
1-2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
healthy male and female subjects of Caucasian race
able to read, to write and to fully understand German language
having given voluntary written informed consent before first invasive screening examination procedure
aged 18 to 45 years, inclusive
BMI of 18 - 28 kg/m2
good health as determined by medical history, physical examination, vital signs, electrocardiogram (ECG, serum/urine biochemistry and hematology)
Exclusion Criteria:
clinically relevant allergy (except for untreated, asymptomatic, seasonal allergies at time of dosing) drug hypersensitivity
known hypersensitivity to one of the IMP substances
severe digestive disorder or surgery of the digestive tract (except for appen¬dectomy)
clinically relevant renal disorders (albuminuria, chronic infections)
clinically relevant hepatic disorders
clinically relevant respiratory disorders
clinically relevant cardiovascular disorders, especially any history of ventricular tachycardia, ventricular fibrillation or multifocal ventricular ectopics, or a history of additional risk factors for torsades de pointes (TdP) (e.g. heart failure, hypokalemia, congenital long QT-syndrome)
diabetes mellitus and thyroid dysfunction or other endocrine disorders
malignancy
substance abuse or addiction (alcohol, illicit drugs) in the past 3 years
neurologic or psychiatric illness
known predisposition to bleeding (e.g. active peptic ulceration, recent (within 6 month) haemorrhagic stroke, surgery within the previous three months, proliferative diabetic retinopathy, poorly controlled hypertension)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Margarete Mueller, Dr.
Organizational Affiliation
AAIPharma Deutschland GmbH & Co. KG
Official's Role
Principal Investigator
Facility Information:
Facility Name
AAIPharma Deutschland GmbH & Co. KG
City
Neu-Ulm
ZIP/Postal Code
89231
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
A Mono-center Study in Healthy Volunteers on the Comparative Bioavailability of Pletal 100 mg Tablets and a New Pletal 100 mg Orodispersible Tablet (ODT), This Latter in Fasting Conditions With and Without Water and Under Fed Conditions
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