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Trial record 16 of 328 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

Tracking Information
First Submitted Date  ICMJE March 24, 2014
First Posted Date  ICMJE March 26, 2014
Results First Submitted Date  ICMJE June 19, 2015
Results First Posted Date  ICMJE July 16, 2015
Last Update Posted Date July 16, 2015
Study Start Date  ICMJE March 2014
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 19, 2015)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 24, 2014)
  • AUC0-168 (Area Under the Concentration-time Curve of Clonidine in Plasma Over the Time Interval From 0 to 168 h) [ Time Frame: up to 168 hours ]
  • Cavg (Average of Measured Concentrations of Clonidine in Plasma on Days 5, 6, and 7) [ Time Frame: on days 5, 6, and 7 ]
Change History Complete list of historical versions of study NCT02096744 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 19, 2015)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 24, 2014)
  • AUC0-8 (area under the concentration-time curve of clonidine in plasma over the time interval from 0 to infinity) [ Time Frame: up to 240 hours ]
  • Cmax (Maximum Concentration of Clonidine in Plasma) [ Time Frame: up to 240 hours ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bioequivalence of Two Transdermal Clonidine Administrations in Healthy Volunteers
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: Catapres-TTS-1
    Catapres-TTS-1 Oppanol
  • Drug: Intervention 1: Catapres-TTS-3
    Catapres-TTS-3 Oppanol
  • Drug: Intervention 2: Catapres-TTS-3
    Catapres-TTS-3 Vistanex
  • Drug: Catapres-TTS-1
    Catapres-TTS-1 Vistanex
Study Arms  ICMJE
  • 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)
    Interventions:
    • Drug: Intervention 1: Catapres-TTS-3
    • Drug: Intervention 2: Catapres-TTS-3
  • 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)
    Interventions:
    • Drug: Intervention 1: Catapres-TTS-3
    • Drug: Intervention 2: Catapres-TTS-3
  • Experimental: Catapres-TTS-1 crossover 1
    subject to receive 0.1 mg/24 hr Catapres-TTS-1 with Oppanol (T2) and Vistanex (R2) simultaneously
    Interventions:
    • Drug: Catapres-TTS-1
    • Drug: Catapres-TTS-1
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 25, 2014)
56
Original Estimated Enrollment  ICMJE
 (submitted: March 24, 2014)
60
Actual Study Completion Date  ICMJE June 2014
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02096744
Other Study ID Numbers  ICMJE 253.2486
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Boehringer Ingelheim
Study Sponsor  ICMJE Boehringer Ingelheim
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
PRS Account Boehringer Ingelheim
Verification Date June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP