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

Valerio Therapeutics

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Catapres 100μg; Drug: Clonidine MBT 100µg; Drug: Clonidine MBT 50µg

Study type: Interventional

Funder types: Industry

Identifiers

NCT02548806

OX2015/28/02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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36 participants in 3 patient groups

Clonidine MBT 50µg

Experimental group

Description:

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.

Treatment:

Drug: Clonidine MBT 50µg

Clonidine MBT 100µg

Experimental group

Description:

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..

Treatment:

Drug: Clonidine MBT 100µg

Catapres 100μg

Active Comparator group

Description:

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.

Treatment:

Drug: Catapres 100μg