Pharmacokinetic Interaction Study Between Budesonide and Metronidazole in Healthy Volunteers

NCT00338910 | Completed Phase 4 DMC

• 1 other identifier: BUC-58/BIO
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Healthy

Keywords

healthy volunteers

Outcome Measures

Primary Outcomes (1)

• AUC

Secondary Outcomes (1)

• other PK parameters

Interventions

Budesonide 2 single doses, Metronidazole multiple-dose DRUG

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.

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital Tuebingen: lead
• Dr. Falk Pharma GmbH: collaborator
• Principal Investigator: Univ. Hosp. Tuebingen, Dept. of Clinical Pharmacology: collaborator

Study Officials

• Christoph H Gleiter, MD

  Department of Clinical Pharmacology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 19, 2006
• First Posted: June 20, 2006
• Study Start: May 1, 2006
• Study Completion: June 1, 2006
• Last Updated: December 11, 2007

Record last verified: 2007-12