Bioequivalence of Two Transdermal Clonidine Administrations in Healthy Volunteers
Condition: Healthy
Intervention: Catapres-TTS-1; Intervention 1: Catapres-TTS-3; Intervention 1: Catapres-TTS-3; Intervention 2: Catapres-TTS-3; Catapres-TTS-1; Intervention 2: Catapres-TTS-3
Intervention description: Catapres-TTS-1 Oppanol; Catapres-TTS-3 Oppanol; Catapres-TTS-3 Oppanol; Catapres-TTS-3 Vistanex; Catapres-TTS-1 Vistanex; Catapres-TTS-3 Vistanex
Intervention MeSH terms: Clonidine
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Enrollment: 56.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      To establish the bioequivalence and adhesion properties of transdermal clonidine prepared
      with Oppanol® brands of polyisobutylene (PIB) vs. transdermal clonidine prepared with
      VistanexTM brands of polyisobutylene (PIB) in healthy male and female volunteers.
    

Eligibility criteria:

        Inclusion criteria:

          1. A complete medical history, including the physical examination, vital signs (BP, PR),
             12-lead ECG, clinical laboratory tests

          2. Age greater than or equal to 18 and Age less than or equal to 65 years

          3. BMI greater than or equal to 18.5 and BMI less than or equal to 32.0 kg/m2 (Body Mass
             Index)

          4. Signed and dated written informed consent prior to admission to the study

          5. 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:

          1. Any finding of the medical examination (including BP, PR and ECG) deviating from
             normal

          2. 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

          3. Any subject with orthostatic hypotension at baseline screening exam

          4. Any laboratory value outside the reference range

          5. Any evidence of a clinically relevant concomitant disease

          6. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic (including
             insulin-dependent diabetes), immunological or hormonal disorders

          7. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders
             (such as depression) or neurological disorders (such as neuropathy)

          8. History of relevant orthostatic hypotension, fainting spells or blackouts

          9. Chronic or relevant acute infections

         10. History of relevant allergy/hypersensitivity

         11. 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.

         12. Use of drugs which might reasonably influence the results of the trial within 10 days
             prior to administration or during the trial

         13. Participation in another trial with an investigational drug within two months prior to
             administration or during the trial

         14. Any concomitant therapy

         15. Smoker

         16. History of alcohol abuse

         17. History of drug abuse

         18. Blood donation

         19. Excessive physical activities (within one week prior to administration or during the
             trial)

         20. Subjects should not swim during the treatment periods of the trial

         21. 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

         22. Pregnancy or planning to become pregnant within two months of study completion

         23. Positive pregnancy test

         24. A screening ECG that displays first-degree atrioventricular block (P-R interval > 0.20
             seconds) or other conduction disturbance