Bioequivalence of Two Transdermal Clonidine Administrations in Healthy Volunteers

NCT ID: NCT02096744

Last Updated: 2015-07-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2014-06-30

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Catapres-TTS-3 crossover 1

subject to receive 0.3 mg/24 hr Catapres-TTS-3 Oppanol (T1) first, followed by Catapres-TTS-3 Vistanex (R1)

Group Type: EXPERIMENTAL

Intervention 1: Catapres-TTS-3

Intervention Type: DRUG

Catapres-TTS-3 Oppanol

Intervention 2: Catapres-TTS-3

Intervention Type: DRUG

Catapres-TTS-3 Vistanex

Catapres-TTS-3 crossover 2

subject to receive 0.3 mg/24 hr Catapres-TTS-3 Vistanex (R1) first, followed by Catapres-TTS-3 Oppanol (T1)

Group Type: EXPERIMENTAL

Intervention 1: Catapres-TTS-3

Intervention Type: DRUG

Catapres-TTS-3 Oppanol

Intervention 2: Catapres-TTS-3

Intervention Type: DRUG

Catapres-TTS-3 Vistanex

Catapres-TTS-1 crossover 1

subject to receive 0.1 mg/24 hr Catapres-TTS-1 with Oppanol (T2) and Vistanex (R2) simultaneously

Group Type: EXPERIMENTAL

Catapres-TTS-1

Intervention Type: DRUG

Catapres-TTS-1 Oppanol

Catapres-TTS-1

Intervention Type: DRUG

Catapres-TTS-1 Vistanex

Interventions

Catapres-TTS-1

Catapres-TTS-1 Oppanol

Intervention Type: DRUG

Intervention 1: Catapres-TTS-3

Catapres-TTS-3 Oppanol

Intervention Type: DRUG

Intervention 1: Catapres-TTS-3

Catapres-TTS-3 Oppanol

Intervention Type: DRUG

Intervention 2: Catapres-TTS-3

Catapres-TTS-3 Vistanex

Intervention Type: DRUG

Catapres-TTS-1

Catapres-TTS-1 Vistanex

Intervention Type: DRUG

Intervention 2: Catapres-TTS-3

Catapres-TTS-3 Vistanex

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

253.2486.1 Boehringer Ingelheim Investigational Site

Austin, Texas, United States

Countries

United States

Other Identifiers

253.2486

Identifier Type: -

Identifier Source: org_study_id