Bioequivalence of Two Transdermal Clonidine Administrations in Healthy Volunteers

Inclusion criteria

• A complete medical history, including the physical examination, vital signs (BP, PR), 12-lead ECG, clinical laboratory tests
• Age greater than or equal to 18 and Age less than or equal to 65 years
• BMI greater than or equal to 18.5 and BMI less than or equal to 32.0 kg/m2 (Body Mass Index)
• Signed and dated written informed consent prior to admission to the study
• Male subjects, or females who meet any of the following criteria from at least 30 days before the first study drug administration and until 30 days after trial completion:
• Using adequate contraception, e.g. any of the following methods plus condom: implants, injectables, combined oral contraceptives, intrauterine device (IUD)
• Sexually abstinent
• Have a vasectomised sexual partner (vasectomy at least one year prior to enrolment)
• Surgically sterilised (including hysterectomy)
• Postmenopausal defined as at least one year of spontaneous amenorrhea

Exclusion criteria

• Any finding of the medical examination (including BP, PR and ECG) deviating from normal
• Repeated measurement of supine systolic blood pressure outside the range of 100-140 mm Hg or diastolic blood pressure outside the range of 60-90 mm Hg or pulse less than 55 bpm
• Any subject with orthostatic hypotension at baseline screening exam
• Any laboratory value outside the reference range
• Any evidence of a clinically relevant concomitant disease
• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic (including insulin-dependent diabetes), immunological or hormonal disorders
• Diseases of the central nervous system (such as epilepsy) or psychiatric disorders (such as depression) or neurological disorders (such as neuropathy)
• History of relevant orthostatic hypotension, fainting spells or blackouts
• Chronic or relevant acute infections
• History of relevant allergy/hypersensitivity
• Intake of drugs with a long half-life (greater than 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial.
• Use of drugs which might reasonably influence the results of the trial within 10 days prior to administration or during the trial
• Participation in another trial with an investigational drug within two months prior to administration or during the trial
• Any concomitant therapy
• Smoker
• History of alcohol abuse
• History of drug abuse
• Blood donation
• Excessive physical activities (within one week prior to administration or during the trial)
• Subjects should not swim during the treatment periods of the trial
• Any condition of the skin, including eczema, psoriasis, or lymphedema, that involves the upper arm in the area that would be utilized for application of the treatments
• Pregnancy or planning to become pregnant within two months of study completion
• Positive pregnancy test
• A screening ECG that displays first-degree atrioventricular block (P-R interval > 0.20 seconds) or other conduction disturbance