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Pharmacokinetic Interaction Study Between Budesonide and Metronidazole in Healthy Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00338910
Recruitment Status : Completed
First Posted : June 20, 2006
Last Update Posted : December 11, 2007
Sponsor:
Collaborators:
Dr. Falk Pharma GmbH
Principal Investigator: Univ. Hosp. Tuebingen, Dept. of Clinical Pharmacology
Information provided by:
University Hospital Tuebingen

Brief Summary:
The primary objective of this study is to describe a possible effect of metronidazole on PK of budesonide in healthy volunteers.

Condition or disease Intervention/treatment Phase
Healthy Drug: Budesonide 2 single doses, Metronidazole multiple-dose Phase 4

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:

  1. Effect of budesonide on metronidazole steady-state PK (primarily described as area under the concentration-time-curve).
  2. Urinary 6β-hydroxycortisol (being a marker of CYP3A activity) and cortisol excretion before and during metronidazole multiple-dose co-administration.
  3. Safety parameters.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pharmacokinetic Interaction Study Between Budesonide and Metronidazole in Healthy Volunteers
Study Start Date : May 2006
Actual Study Completion Date : June 2006

Resource links provided by the National Library of Medicine



Intervention Details:
  • Drug: Budesonide 2 single doses, Metronidazole multiple-dose
    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.


Primary Outcome Measures :
  1. AUC

Secondary Outcome Measures :
  1. other PK parameters


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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
  • 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

Exclusion Criteria:

  • 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
  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00338910


Sponsors and Collaborators
University Hospital Tuebingen
Dr. Falk Pharma GmbH
Principal Investigator: Univ. Hosp. Tuebingen, Dept. of Clinical Pharmacology
Investigators
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Principal Investigator: Christoph H Gleiter, MD Department of Clinical Pharmacology
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ClinicalTrials.gov Identifier: NCT00338910    
Other Study ID Numbers: BUC-58/BIO
First Posted: June 20, 2006    Key Record Dates
Last Update Posted: December 11, 2007
Last Verified: December 2007
Keywords provided by University Hospital Tuebingen:
healthy volunteers
Additional relevant MeSH terms:
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Metronidazole
Budesonide
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Infective Agents
Anti-Bacterial Agents
Antiprotozoal Agents
Antiparasitic Agents