Comparative assessment of the absorption of a single oral dose of beclomethasone dipropionate in healthy male and female volunteers with and without concurrent oral charcoal blockade.

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12614000990628
• Date of registration: 15/09/2014
• Prospective Registration: Yes
• Primary sponsor: Zenith Technology Corporation Limited
• Public title: Comparative assessment of the absorption of a single oral dose of beclomethasone dipropionate in healthy male and female volunteers with and without concurrent oral charcoal blockade.
• Scientific title: A single dose, randomized, open label, crossover comparative bioavailability study of beclomethasone dipropionate in healthy male and female volunteers under fasting conditions with and without concurrent oral charcoal blockade.
• Date of first enrolment: 29/09/2014
• Target sample size: 24
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12614000990628.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Crossover;Type of endpoint: Bio-availability;
• Phase: Phase 1

Countries of recruitment

New Zealand

Contacts

• Name: Mrs Linda Folland

• Name: Dr Cheung Tak Hung

Key inclusion & exclusion criteria

Inclusion criteria: Healthy male and non-pregnant females
Aged between 18 and 45
Non-smoker
BMI between 18.5 and 30 inclusive
Normal, healthy individuals as determined by medical history, physical examination, ECG, blood pressure, pulse, heart rate, temperature, well-being assessment and laboratory tests
Able to provide written informed consent

Exclusion criteria: Any history of COPD, chronic bronchitis, emphysema, asthma , or any other lung disease, recent upper or lower respiratory tract infection, migraine headaches
Concomitant drug therapy of any kind
Who have taken any drug that induces/inhibits the hepatic microsomal enzymes within 30 days prior to dosing
Who have received an investigational compound or drug known to induce or inhibit liver enzymes within 60 days of the start of the study
Sensitivity to beclomethasone dipropionate any other similar class medicines or the excipients of beclomethasone dipropionate
Any history of recent recurrent attacks of bronchitis, asthma, migraine headaches
Concomitant drug therapy of any kind
History of any conditions that might interfere with the absorption, distribution, metabolism or excretion of the drug
Females who are pregnant and/or are breastfeeding
Who are planning to start a family within 60 days of receiving the final dose.
Smoker (anyone who has smoked in the last 6 months)
History of alcohol or drug abuse or dependency
Participation in a drug study within 60 days of the start of the study or donated blood in the 60 days preceding the study.
Volunteers for whom the Clinical Investigator believes, for any reason, that participation would not be an acceptable risk

Age minimum: 18 Years
Age maximum: 45 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Other - Research that is not of generic health relevance and not applicable to specific health categories listed above

Bioavailability study conducted in healthy volunteers comparing beclomethasone dipropionate administered with and without concurrent charcoal dosing with no health condition or problem studied. Although this study is being conducted in healthy volunteers who are not being treated for the condition to which the medicine is used, beclomethasone dipropionate belongs to a class of medicines called synthetic corticosteroids. It is used for the treatment of symptoms of seasonal allergic rhinitis including hay fever.;
Bioavailability study conducted in healthy volunteers comparing beclomethasone dipropionate administered with and without concurrent charcoal dosing with no health condition or problem studied.

Although this study is being conducted in healthy volunteers who are not being treated for the condition to which the medicine is used, beclomethasone dipropionate belongs to a class of medicines called synthetic corticosteroids. It is used for the treatment of symptoms of seasonal allergic rhinitis including hay fever.

Intervention(s)

Single dose, crossover study design whereby each participant receives the formulation of beclomethasone dipropionate (1 x 2000 mcg) on one occasion with oral charcoal administered pre-dose and at specified times up to 4 hours post dosing and on one occasion without oral charcoal with each dose separated by a one week washout period. The intervention for this trial is beclomethasone dipropionate with and without charcoal.

No water is allowed for 1 hour prior to dosing until 1 hour after dosing (except for the water consumed with the dose).
Participants are required not to eat for 10 hours before receiving each dose and to fast for approximately 4 hours after receiving each dose.

Bathroom visits will be supervised to ensure no unauthorised water or food intake and for personal safety. Participants will be confined at the Clinical Site for 10 hours prior to dosing to ensure compliance and will be monitored and for 24 hours after dosing.

Standard meals will be consumed at the Clinical Site with no additional food intake allowed.

Vital sign examination, assessment of well-being, a throat examination, alcohol breath testing, drug testing and pregnancy testing will be performed upon each participant reporting to the Clinical Site 10 hours prior to dosing.

Pre and post study laboratory tests will be completed to assess the healthy of participants along with HIV, Hepatitis and drugs of abuse testing.

The volunteer's randomsied to receive 50 ml of activated charcoal suspension will be given the charcoal suspension 2 minutes prior to dosing, immediately with dosing and also at 1, 2 and 4 hours post dosing.

Each dose (1 x 2000 mcg) will be taken orally as 2 ml of beclomethasone dipropionate nasal spray suspension in 18 ml of wa

Primary Outcome(s)

To compare the bioavailability of beclomethasone dipropionate and 17-BMP (as summarised by Cmax and AUC) with and without concurrent oral charcoal. All plasma samples will be assayed for beclomethasone dipropionate using one fully validated LC/MS/MS method. Validation will be conducted to comply with EU and FDA guidelines. [0, 0.08, 0.025, 0.50, 0.75, 1, 1.5, 1.75, 2, 3, 4, 6, 8, 10, 12, 16, 20 and 24 hours ]

Secondary Outcome(s)

Time to maximum peak concentration (Tmax) will be determined by plasma sample analysis. Tmax will be the time where the maximum concentration occurred in the sample points. [0, 0.08, 0.025, 0.50, 0.75, 1, 1.5, 1.75, 2, 3, 4, 6, 8, 10, 12, 16, 20 and 24 hours ]

Secondary ID(s)

None

Source(s) of Monetary Support

Cipla Ltd

Ethics review

Status: Approved
Approval date:
Contact:

Northern Health and Disability Ethics Committee