Status:
COMPLETED
Evaluation of Systemic Bioavailability and Effects on 24-Hour Plasma Cortisol Profile of 6 mg Delivered Once Daily Versus 3 mg Delivered Twice Daily in Healthy Adult Male Volunteers
Lead Sponsor:
SOFAR S.p.A.
Conditions:
Healthy Adult Male Volunteers
Eligibility:
MALE
18-55 years
Phase:
PHASE1
Brief Summary
Single-centre, randomized, double-blind, two-period, two-sequence, cross-over 7-day study. This study is the first safety/tolerability evaluation of a product -suppository formulation containing 6 mg...
Detailed Description
Primary objective is the evaluation of systemic safety of T, based on valid surrogate outcomes - systemic BA (relative BA) at the start of treatment (first 24 hours) and after 7 days of continuous tre...
Eligibility Criteria
Inclusion
- Healthy male, aged between 18 and 55 years. Healthy subjects are defined as individuals who are free from clinically significant illness or disease as determined by their medical history, physical examination, laboratory and other (e.g. ECG) tests.
- BMI 19.0 - 29.0 kg/m2;
- Signed and dated written informed consent of the subject to participate in the clinical study;
- The subject is willing to refrain from the use of illicit drugs and alcohol and to adhere to other protocol-stated restrictions while participating in the study;
- The subject is able to understand and comply with the protocol requirements and instructions and is likely to complete the study as planned;
- Non-smoker for at least 3 months.
Exclusion
- Subject with a significant abnormality in the past and/or at the Screening that influences the present general health condition and requires pharmacological treatment during the study;
- History of serious allergic diseases, including allergy to medicinal products, which in opinion of the investigator, contraindicates participation to the trial;
- History of diseases of the alimentary tract, liver or kidneys that may influence absorption, distribution and elimination;
- History of average alcohol consumption;
- Hypersensitivity to BDP or study products inactive ingredients;
- Use of any pharmacological treatments (including high dose vitamins, lozenges, herbal and dietary supplements), with the exception of paracetamol ≤ 1 g/daily, within 15 days before the admission to the study Site in the Period 1;
- Use of steroids, anabolic or hormonal therapy within 3 months before the admission to the study Site in the Period 1;
- Laboratory indication of adrenocortical dysfunction;
- Blood loss exceeding 200 ml over the last 4 weeks before the day of Screening;
- Positive results to Sars Cov-2 nasopharyngeal swab;
- Positive results of HBsAg, anti-HCV, anti-HIV tests;
- Blood pressure: systolic \>140mmHg or \< 90mmHg, diastolic \<60 mmHg or \>90 mmHg during screening procedures;
- Subject who adhere to a special diet (e.g. low calories, vegetarian etc.);
- Consumption of products containing methylxanthines in the following average quantities: \> 3 cups of 200 ml of strong coffee a day;
- Presence of metabolites of illicit drugs (opioids, cannabis) during screening procedures;
- Participation in other clinical trials during the 6 months preceding the study, counting from the day of last product administration.
Key Trial Info
Start Date :
October 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 28 2022
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT04873063
Start Date
October 22 2021
End Date
April 28 2022
Last Update
May 4 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Centro Ricerche Cliniche AOU Integrata di Verona - Policlinico Universitario G.B. Rossi
Verona, Italy, 37134