HealthyPhase 4NCT00338910
Pharmacokinetic Interaction Study Between Budesonide and Metronidazole in Healthy Volunteers
A Phase 4 study testing Budesonide 2 single doses, Metronidazole multiple-dose in people with Healthy, run by University Hospital Tuebingen.
Trial summary
The primary objective of this study is to describe a possible effect of metronidazole on PK of budesonide in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Budesonide 2 single doses, Metronidazole multiple-dose
- Type of treatment
- Pill or oral medicine
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- May 2006to Jun 2006
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male subjects
- Caucasian origin
- Age: between 18 and 55 years (inclusive)
- Body mass index (BMI) within 18-30 kg/m²
- Body weight at least 50 kg, at most 100 kg
- Non-smoker (or ex-smoker ≥1 year), proven by urine cotinine <500 ng/ml
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- Clinically acceptable supine blood pressure and pulse rate, i.e. BP 100-145 mmHg systolic, 60-90 mmHg diastolic and pulse rate 50-100 bpm
- Normal ECG
- Participants must perform an adequate contraception during the study and until 6 months after the last dose of the present trial
- Ability to communicate well with the investigator and comply with the requirements of the entire study
- Written consent
Who cannot join
- Subjects with contraindications for budesonide
- Subjects with contraindications for metronidazole
- History or current clinical evidence of any cardiac, cardio-vascular, pulmonary, gastrointestinal, (cholangio-)hepatic, renal, endocrine, neurological, musculoskeletal, ophthalmological, infectious, haematological, oncological, psychiatric, or other acute or chronic diseases and/or pathological findings which might interfere with the drugs' safety, tolerability, absorption and/or pharmacokinetics
- History or current evidence of clinically relevant allergies or idiosyncrasy to drugs or food
- Clinically relevant abnormalities in clinical chemical, hematological or any other laboratory variables
- Current smoker or ex-smoker ≤ 1 year
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- Excessive alcohol consumption (³ 35 g/day in males)
- Abuse of drugs
- Positive drug screening
- Positive anti-HIV-test, HBsAg-test or anti-HCV-test
- Proneness to orthostatic dysregulation, faintings, or blackouts
- Heavy tea or coffee drinkers (more than 1 l ≈ 6 cups per day)
- Administration of glucocorticosteroids within 6 weeks prior to study day 1 or during the trial
- Repeated use of drugs during the last 4 weeks prior to study day 1 or during the trial, which might influence hepatic biotransformation
- Any medication including OTC medication within the last 14 days prior to study day 1 or during the trial (single intake of a drug may be accepted if judged by the investigators to have no clinical relevance and no relevance for the study objectives)
- Intake of grapefruit-containing food or beverages within 7 days prior to study day 1 or during the trial
- Clinically relevant acute or chronic bacterial, fungal or viral infections
- Surgery of the gastrointestinal tract which may interfere with drug absorption (not applicable for minor abdominal surgery such as e.g. appendectomy and herniotomy)
- Vegetarian diet or other peculiar dietary habits which would preclude the subject's acceptance of standardized (non-vegetarian) meals
- Subjects suspected or known not to follow instructions
- Subjects who are unable to understand the written and verbal instructions, in particular regarding the risks and inconveniences they will be exposed to as a result of their participation in the study
- Patients known to be in financial difficulties, which could interfere with their appraisal of the informative instructions
- Vulnerable subjects (e.g., persons kept in detention or persons who are depending on the sponsor or the investigator)
- Blood donation or other blood loss of more than 400 ml within the last 2 months prior to study day 1
- Participation in a clinical trial within the last 2 months prior to study day 1 (assessed by anamnestic inquiry)
About this study
The primary objective of this study is to describe a possible effect of metronidazole on PK of budesonide in healthy volunteers.
Read the detailed description
The primary objective of this study is to describe a possible effect of metronidazole on PK of budesonide in healthy volunteers.
Secondary objectives:
- Effect of budesonide on metronidazole steady-state PK (primarily described as area under the concentration-time-curve).
- Urinary 6β-hydroxycortisol (being a marker of CYP3A activity) and cortisol excretion before and during metronidazole multiple-dose co-administration.
- Safety parameters.
- Conditions
- Healthy
- Being tested
- Budesonide 2 single doses, Metronidazole multiple-dose
- Keywords
- healthy volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Budesonide 2 single doses, Metronidazole multiple-doseDrug
Budesonide 3 mg single oral dose on Day 1 and Day 9. Metronidazole 750 mg b.i.d. from Day 2 until Day 8, Metronidazole 750 mg once daily (in the morning) on Day 9.
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC
Secondary outcomes (1)
other PK parameters
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2006 (estimated)
- Study startMay 2006
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Collaborators
- Dr. Falk Pharma GmbH, Principal Investigator: Univ. Hosp. Tuebingen, Dept. of Clinical Pharmacology
- Investigators
- Christoph H Gleiter, MD, Principal investigator, Department of Clinical Pharmacology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00338910
- Sponsor's protocol ID
- BUC-58/BIO
- Status last verified
- Dec 2007
- First submitted
- 19 Jun 2006
- Last updated
- 11 Dec 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic Interaction Study Between Budesonide and Metronidazole in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00338910
- Acronym / sponsor ID
- BUC-58/BIO
- Conditions
- Healthy
- Keywords
- healthy volunteers
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Collaborators
- Dr. Falk Pharma GmbH, Principal Investigator: Univ. Hosp. Tuebingen, Dept. of Clinical Pharmacology
- Study start
- May 2006
- Study completion
- Jun 2006 (actual)
- First posted
- 20 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to describe a possible effect of metronidazole on PK of budesonide in healthy volunteers.
Detailed description
The primary objective of this study is to describe a possible effect of metronidazole on PK of budesonide in healthy volunteers.
Secondary objectives:
- Effect of budesonide on metronidazole steady-state PK (primarily described as area under the concentration-time-curve).
- Urinary 6β-hydroxycortisol (being a marker of CYP3A activity) and cortisol excretion before and during metronidazole multiple-dose co-administration.
- Safety parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Healthy male subjects
- Caucasian origin
- Age: between 18 and 55 years (inclusive)
- Body mass index (BMI) within 18-30 kg/m²
- Body weight at least 50 kg, at most 100 kg
Key exclusion criteria (25 listed)
- Subjects with contraindications for budesonide
- Subjects with contraindications for metronidazole
- History or current clinical evidence of any cardiac, cardio-vascular, pulmonary, gastrointestinal, (cholangio-)hepatic, renal, endocrine, neurological, musculoskeletal, ophthalmological, infectious, haematological, oncological, psychiatric, or other acute or chronic diseases and/or pathological findings which might interfere with the drugs' safety, tolerability, absorption and/or pharmacokinetics
- History or current evidence of clinically relevant allergies or idiosyncrasy to drugs or food
- Clinically relevant abnormalities in clinical chemical, hematological or any other laboratory variables
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Budesonide 2 single doses, Metronidazole multiple-doseBudesonide 3 mg single oral dose on Day 1 and Day 9. Metronidazole 750 mg b.i.d. from Day 2 until Day 8, Metronidazole 750 mg once daily (in the morning) on Day 9. | Drug | – |
Primary outcome
AUC
1 secondary outcome
other PK parameters
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christoph H Gleiter, MD principal investigator
Department of Clinical Pharmacology
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Budesonide 2 single doses, Metronidazole multiple-dose in people with Healthy, run by University Hospital Tuebingen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2007.