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Trial record 2 of 306 for:    Clonidine

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

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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Clonidine MBT 50µg Drug: Clonidine MBT 100µg Drug: Catapres 100μg Phase 1

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 : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : September 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Drug: Clonidine MBT 50µg
Clonidine MBT 50µg, single dose
Other Name: Clonidine Lauriad

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..
Drug: Clonidine MBT 100µg
Clonidine MBT 100µg, single dose
Other Name: Clonidine Lauriad

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.
Drug: Catapres 100μg
Catapres tablet 100μg, single dose
Other Name: Catapres




Primary Outcome Measures :
  1. 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)

  2. 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)


Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

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): NCT02548806


Locations
United Kingdom
Simbec Research Limited
Merthyr Tydfil, United Kingdom, CF48 4DR
Sponsors and Collaborators
Onxeo
Simbec Research
Investigators
Principal Investigator: Girish Sharma, MD Simbec Research

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Onxeo
ClinicalTrials.gov Identifier: NCT02548806     History of Changes
Other Study ID Numbers: OX2015/28/02
First Posted: September 14, 2015    Key Record Dates
Last Update Posted: April 18, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: presentation at ESMO congress

Keywords provided by Onxeo:
Clonidine

Additional relevant MeSH terms:
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