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

NCT00773630 | Completed Phase 1

• 1 other identifier: 21-08-101
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Intermittent Claudication

Outcome Measures

Primary Outcomes (1)

• Area under the curve, maximal concentration (Cmax)

  1-2 months

Secondary Outcomes (1)

• Time of maximum (tmax), Vss/f, CL/f)

  1-2 months

Study Arms (4)

A

ACTIVE COMPARATOR

Intake of Pletal 100 mg tablets dose together with 200 ml water

Drug: Cilostazol

B

EXPERIMENTAL

Intake of Pletal 100 mg ODT dose without water

Drug: Cilostazol

C

EXPERIMENTAL

Intake of Pletal 100 mg ODT dose together with 200 ml water

Drug: Cilostazol

D

ACTIVE COMPARATOR

Intake of Pletal 100 mg ODT dose without water

Drug: Cilostazol

Interventions

Cilostazol DRUG

100 mg Cilostazol

A; B; C; D

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Otsuka Frankfurt Research Institute GmbH: lead

Study Sites (1)

AAIPharma Deutschland GmbH & Co. KG

Neu-Ulm, 89231, Germany

Location

MeSH Terms

Conditions

Intermittent Claudication

Interventions

Cilostazol

Condition Hierarchy (Ancestors)

Peripheral Arterial Disease; Peripheral Vascular Diseases; Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Margarete Mueller, Dr.

  AAIPharma Deutschland GmbH & Co. KG

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2008
• First Posted: October 16, 2008
• Study Start: December 1, 2008
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: September 9, 2011

Record last verified: 2009-03

Locations

DE (1)