Clinical trial NCT02096744: Bioequivalence of Two Transdermal Clonidine Administrations in Healthy Volunteers
Official title: A Randomized, Double-blind Study Designed to Assess the Bioequivalence and Adhesion Properties of Transdermal Clonidine-VistanexTM Compared to Transdermal Clonidine-Oppanol® Following Transdermal Administration in Healthy Male and Female Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-03-26
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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

Primary outcomes:
measure: AUC0-168 (Area Under the Concentration-time Curve of Clonidine in Plasma Over the Time Interval From 0 to 168 h)
timeFrame: 1 hour (h) before patch administration and 12h, 24h, 48h, 72h, 96h, 120h, 144h, 168h after patch administration
measure: Cavg (Average of Measured Concentrations of Clonidine in Plasma on Days 5, 6, and 7)
timeFrame: 1 hour (h) before patch administration and 12h, 24h, 48h, 72h, 96h, 120h, 144h, 168h, 192h, 216h, 240h after patch administration
Secondary outcomes:
measure: AUC0-inf(Area Under the Concentration-time Curve of Clonidine in Plasma Over the Time Interval From 0 to Infinity)
timeFrame: 1 hour (h) before patch administration and 12h, 24h, 48h, 72h, 96h, 120h, 144h, 168h, 192h, 216h, 240h after patch administration
measure: Cmax (Maximum Concentration of Clonidine in Plasma)
timeFrame: 1 hour (h) before patch administration and 12h, 24h, 48h, 72h, 96h, 120h, 144h, 168h, 192h, 216h, 240h after patch administration
Other outcomes:
Locations:
city: Austin
country: United States
facility: 253.2486.1 Boehringer Ingelheim Investigational Site
state: Texas
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: