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Trial record 16 of 326 for:    clonidine

Bioequivalence of Two Transdermal Clonidine Administrations in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT02096744
Recruitment Status : Completed
First Posted : March 26, 2014
Results First Posted : July 16, 2015
Last Update Posted : July 16, 2015
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Catapres-TTS-1 Drug: Intervention 1: Catapres-TTS-3 Drug: Intervention 2: Catapres-TTS-3 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
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 Start Date : March 2014
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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)
Drug: Intervention 1: Catapres-TTS-3
Catapres-TTS-3 Oppanol

Drug: Intervention 2: Catapres-TTS-3
Catapres-TTS-3 Vistanex

Experimental: 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)
Drug: Intervention 1: Catapres-TTS-3
Catapres-TTS-3 Oppanol

Drug: Intervention 2: Catapres-TTS-3
Catapres-TTS-3 Vistanex

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

Drug: Catapres-TTS-1
Catapres-TTS-1 Vistanex




Primary Outcome Measures :
  1. AUC0-168 (Area Under the Concentration-time Curve of Clonidine in Plasma Over the Time Interval From 0 to 168 h) [ Time Frame: 1 hour (h) before patch administration and 12h, 24h, 48h, 72h, 96h, 120h, 144h, 168h after patch administration ]
    AUC0-168 (area under the concentration-time curve of clonidine in plasma over the time interval from 0 to 168 h) The values for geometric mean and geometric coefficient of variation (gCV) are actually adjusted geometric means and adjusted intra-individual gCVs, respectively.

  2. Cavg (Average of Measured Concentrations of Clonidine in Plasma on Days 5, 6, and 7) [ Time Frame: 1 hour (h) before patch administration and 12h, 24h, 48h, 72h, 96h, 120h, 144h, 168h, 192h, 216h, 240h after patch administration ]
    Cavg (average of measured concentrations of clonidine in plasma on Days 5, 6, and 7) The values for geometric mean and gCV are actually adjusted geometric means and adjusted intra-individual gCVs, respectively.


Secondary Outcome Measures :
  1. AUC0-inf(Area Under the Concentration-time Curve of Clonidine in Plasma Over the Time Interval From 0 to Infinity) [ Time Frame: 1 hour (h) before patch administration and 12h, 24h, 48h, 72h, 96h, 120h, 144h, 168h, 192h, 216h, 240h after patch administration ]
    AUC 0-inf(area under the concentration-time curve of clonidine in plasma over the time interval from 0 to infinity) The values for geometric mean and gCV are actually adjusted geometric means and adjusted intra-individual gCVs, respectively.

  2. Cmax (Maximum Concentration of Clonidine in Plasma) [ Time Frame: 1 hour (h) before patch administration and 12h, 24h, 48h, 72h, 96h, 120h, 144h, 168h, 192h, 216h, 240h after patch administration ]
    Cmax (maximum concentration of clonidine in plasma) The values for geometric mean and gCV are actually adjusted geometric means and adjusted intra-individual gCVs, respectively.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02096744


Locations
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United States, Texas
253.2486.1 Boehringer Ingelheim Investigational Site
Austin, Texas, United States
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim

Additional Information:
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02096744     History of Changes
Other Study ID Numbers: 253.2486
First Posted: March 26, 2014    Key Record Dates
Results First Posted: July 16, 2015
Last Update Posted: July 16, 2015
Last Verified: June 2015
Additional relevant MeSH terms:
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Clonidine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action