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.

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.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12614000990628

Enrollment

Registered

2014-09-15

Start date

2014-09-29

Completion date

2014-09-30

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The objective of this study is to evaluate the bioavailability of beclomethasone dipropionate in healthy male and female volunteers under fasting conditions with and without concurrent oral charcoal.

Interventions

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 water. Medication will be administered via a 30 ml syringe and a mouth check will be conducted to ensure the medication has been taken as directed.

Study design

Allocation

Randomised controlled trial

Intervention model

Crossover

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to 45 Years

Healthy volunteers

Yes

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

Outcome results