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Trial record 6 of 731 for:    Area Under Curve AND Bioavailability

Phase 1 PK, Bioavailability, Safety Study of Clonidine MBT w Catapres in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT02548806
Recruitment Status : Completed
First Posted : September 14, 2015
Last Update Posted : April 18, 2016
Sponsor:
Collaborator:
Simbec Research
Information provided by (Responsible Party):
Onxeo

Tracking Information
First Submitted Date  ICMJE September 2, 2015
First Posted Date  ICMJE September 14, 2015
Last Update Posted Date April 18, 2016
Study Start Date  ICMJE September 2015
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 10, 2015)
  • Dose proportionality of two strengths of clonidine MBT (50μg and 100 μg) as assessed by Non-compartmental pharmacokinetic analysis (Area Under the Curve) [ Time Frame: 3 Months ]
    To evaluate dose proportionality of two strengths (50 μg and 100 μg) of Clonidine MBT, by using Area Under the Curve (AUC)
  • Bioavailability of clonidine from Clonidine MBT 50 μg and 100 μg with that from oral clonidine hydrochloride 100 μg tablets. (Area Under the Curve) [ Time Frame: 3 Months ]
    To compare the bioavailability of clonidine from Clonidine MBT® 50 μg and 100 μg with that from oral clonidine hydrochloride 100 μg tablets, by using Area Under the Curve (AUC)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02548806 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 10, 2015)
General safety information (adverse events, (AEs), 12-lead electrocardiogram (ECG) and vital signs), during the study period. [ Time Frame: 3 Months ]
Number of Participants With Treatment-Related Adverse Events as Assessed by Common Toxicity Criteria for Adverse Effects (CTCAE v4.0), 12-lead electrocardiogram (ECG) and vital signs
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase 1 PK, Bioavailability, Safety Study of Clonidine MBT w Catapres in Healthy Volunteers
Official Title  ICMJE Randomised Single Dose 3 Way Crossover Single Blind Study to Evaluate the Pharmacokinetic Dose Proportionality, Compare the Bioavailability and Safety of Clonidine Mucoadhesive Buccal Tablets (MBT) With Catapres in Normal Healthy Volunteers
Brief Summary The purpose of this study is to determine the pharmacokinetic dose proportionality of 50 μg and 100 μg Clonidine and comparative bioavailability of clonidine with that from the Reference drug, Catapres® 100 μg oral tablets following single dose administration in healthy subjects.
Detailed Description

A single blind, randomised, 3-period, 3-sequence single-dose crossover study to determine the pharmacokinetic dose proportionality of Clonidine MBT 50 μg and Clonidine MBT 100 μg and comparative bioavailability of clonidine from the Reference drug, Catapres® 100 μg oral tablets following single dose administration in healthy male and female subjects.

36 subjects will be randomised for 30 to complete the study. The study will comprise of 3 Treatment Periods (1, 2 and 3) and a post study follow up (7 - 12 days after the last dose). Study drug will be administered on the morning of Day 1. Pharmacokinetic (PK) blood samples will be collected for each of three treatment periods. Safety will be evaluated at specified times throughout the study. There will be at least 7 days between dose administrations.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: Clonidine MBT 50µg
    Clonidine MBT 50µg, single dose
    Other Name: Clonidine Lauriad
  • Drug: Clonidine MBT 100µg
    Clonidine MBT 100µg, single dose
    Other Name: Clonidine Lauriad
  • Drug: Catapres 100μg
    Catapres tablet 100μg, single dose
    Other Name: Catapres
Study Arms  ICMJE
  • Experimental: Clonidine MBT 50µg
    Each subject will receive the following treatments in random order over 3 Treatment Periods (1 treatment/period): Clonidine MBT 50µg single dose, Clonidine MBT 100μg single dose ,a single-dose of reference catapres 100μg tablets.
    Intervention: Drug: Clonidine MBT 50µg
  • Experimental: Clonidine MBT 100µg
    Each subject will receive the following treatments in random order over 3 Treatment Periods (1 treatment/period): Clonidine MBT 50μg single dose, Clonidine MBT 100µg single dose ,a single-dose of reference catapres 100μg tablets..
    Intervention: Drug: Clonidine MBT 100µg
  • Active Comparator: Catapres 100μg
    Each subject will receive the following treatments in random order over 3 Treatment Periods (1 treatment/period): Clonidine MBT 50μg single dose, Clonidine MBT 100μg single dose ,a single-dose of reference catapres 100μg tablets.
    Intervention: Drug: Catapres 100μg
Publications * Vasseur B, Dufour A, Houdas L, Goodwin H, Harries K, Emul NY, Hutchings S. Comparison of the Systemic and Local Pharmacokinetics of Clonidine Mucoadhesive Buccal Tablets with Reference Clonidine Oral Tablets in Healthy Volunteers: An Open-Label Randomised Cross-Over Trial. Adv Ther. 2017 Aug;34(8):2022-2032. doi: 10.1007/s12325-017-0585-9. Epub 2017 Jul 19.

*   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: September 10, 2015)
36
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2016
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Main Inclusion Criteria:

  • Healthy males or females (non-pregnant/non-lactating) aged 18 - 50 years.
  • A Body Mass Index (BMI) of 18-30.
  • No clinically significant abnormal serum biochemistry, haematology and urine examination values.
  • A negative urinary drugs of abuse screen.
  • Negative HIV and Hepatitis B and C results.
  • No clinically significant abnormalities in 12-lead electrocardiogram (ECG).
  • No clinically significant abnormalities in blood pressure or pulse.
  • No allergy or sensitivity to clonidine or any of its excipients.
  • No allergy to milk or milk derivatives.
  • Subjects must provide written informed consent to participate in the study

Main Exclusion Criteria:

  • Current or past medical condition that might significantly affect the pharmacokinetic or
  • pharmacodynamic response to clonidine.
  • Participation in a New Chemical Entity clinical study within the previous 3 months or a marketed drug clinical study within the previous 30 days.
  • Pathological condition of the oral cavity that would affect administration via the buccal route.
  • Raynaud's disease or other peripheral vascular disease.
  • Receipt of regular medication within 14 days of the first dose that may have an impact on the safety and objectives of the study (at the Investigator's discretion).
  • Evidence of renal, hepatic, central nervous system, respiratory, cardiovascular or metabolic dysfunction.
  • Symptomatic postural hypotension evident on screening
  • History or evidence of Suicidal Ideation and/or behaviour as determined by using Columbia-Suicide Severity Rating Scale (C-SSRS)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02548806
Other Study ID Numbers  ICMJE OX2015/28/02
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: presentation at ESMO congress
Responsible Party Onxeo
Study Sponsor  ICMJE Onxeo
Collaborators  ICMJE Simbec Research
Investigators  ICMJE
Principal Investigator: Girish Sharma, MD Simbec Research
PRS Account Onxeo
Verification Date April 2016

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