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OpenTrials
Completed

NCT Number: NCT00773630

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

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.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

AAIPharma Deutschland GmbH & Co. KG

Neu-Ulm, 89231, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Cilostazol

Drug

100 mg Cilostazol

Primary outcomes

  1. Area under the curve, maximal concentration (Cmax)

    Time frame: 1-2 months

Secondary outcomes

  1. Time of maximum (tmax), Vss/f, CL/f)

    Time frame: 1-2 months

Sponsors and collaborators

Lead sponsor

Otsuka Frankfurt Research Institute GmbH

Industry

Registry information

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Oct 16, 2008
Registry last updated
Sep 9, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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