A randomised, two-period two-stage cross-over study on the relative bioavailability of two different formulations of single doses of rifampicin (phase I/IV, open-label) in healthy volunteers (fasted state)
- Conditions
- healthy volunteers
- Registration Number
- DRKS00014602
- Lead Sponsor
- InfectoPharm Arzneimittel und Consilium GmbH (Ansprechpartner: Dr. Bertil Wachall)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 24
• Body Mass Index 18.5 – 30 kg/m2
• Considered healthy on the basis of extensive pre-study screening
• Willing and capable to confirm written consent to enrolment and having given written informed consent after ample information has been provided
• subjects with suspicion of hypersensitivity to rifampicin, other rifamycines, or any of the excipients listed in the respective medical product information
• subjects with any relevant clinical abnormality (as based on extensive medical history, physical examination, vital signs [i.e., pulse rate outside the interval of 50-90 beats per minute and blood pressure outside the 90-140 mmHg (systolic) and/or 60-90 mmHg (diastolic) intervals] and 12-lead ECG)
• subjects with a history of a major surgical abdominal intervention or of peritonitis within the last year
• subjects with psychoses (current or history)
• subjects with any clinically relevant laboratory abnormality; clinically relevant laboratory abnormality is formally defined as follows:
- Serology for hepatitis and HIV: any positive result in the initial examination which is confirmed by a second examination
- Urine screen for substances of abuse: any positive result in the initial examination which is confirmed by a second examination
- Urinalysis (Combur 10®): any more than borderline positive result in the initial examination which is confirmed by a second examination (no limitations apply for pH)
-Haematocrit, haemoglobin, mean corpuscular volume (MCV), mean corpuscular haemoglobin (MCH), mean corpuscular haemoglobin concentration (MCHC), erythrocyte count (RBC), total leukocyte count, platelet count, prothrombin time (Quick), activated partial thromboplastin time (aPTT), alanine aminotransferase (ALT), potassium, sodium, , glucose: any value more than 10 %, and AST aspartate aminotransferase (AST): any value more than 20% outside the respective reference range in the initial examination which is confirmed by a second examination
- -Creatinine: slight decrease of 10 % (lower level of normal) and slight elevation of 0.1 mg/dl above upper limit of normal are acceptable 10
- gamma -glutamyl transpeptidase (?-GT), alkaline phosphatase (AP), lactate dehydrogenase (LDH), total protein, albumin, urea, uric acid, thyroid-stimulating hormone (TSH): any value more than 20 % outside the respective reference range in the initial examination which is confirmed by a second examination
- total bilirubin, direct bilirubin: any value more than 20 %, total cholesterol, triglycerides, differential leukocyte count: any value more than 50 % outside the respective reference range in the initial examination which is confirmed by a second examination
Exceptions are possible upon decision of the Principal Investigator (e.g. exclusion of a subject with a less than 10 % elevation above the reference range for ?-GT, ALT or with a less than 20 % elevation above the reference range for AST).
• subjects receiving any medication within 1 week prior to study start or during the study (exceptions possible upon decision of Principal Investigator, e.g. ibuprofen single dose for acute pain or topical aciclovir for herpes labialis)
• subjects who have taken a drug with a long half-life (> 24 h) within four weeks before the first trial day (exceptions possible upon decision of Principal Investigator)
• subjects who received chronic drug treatment (> 3 days) within eight weeks before the first trial day (exceptions possible upon decision of Principal Investigator)
• subjects who participated in a trial with novel investigational medications within the last 8 weeks before the start of the present study
• subjects who participated in a trial with a registered compound within the last 4 weeks before the start of the p
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Parameters: AUC0-t(last) and Cmax for the comparison of the biavailibility of the two preparations.<br>For this purpose, blood samples are taken at different times within 24 hours after the administration of the drug in order to measure the concentration of the active substance in the blood.
- Secondary Outcome Measures
Name Time Method Additional pharmacokinetic parameters of rifampicin: AUC0-8, residual area, tmax, ?z (apparent terminal elimination constant), t½(apparent terminal elimination half-life);<br>Safety: Safety and Tolerability of both preparations.<br>For this purpose, blood samples are taken at different times within 24 hours after the administration of the drug in order to measure the concentration of the active substance in the blood.