Pharmacokinetic Investigation of UDCA in Bile and Serum
This study has been completed.
Sponsor:
Dr. Falk Pharma GmbH
Information provided by:
Dr. Falk Pharma GmbH
ClinicalTrials.gov Identifier:
NCT00529009
First received: September 12, 2007
Last updated: May 5, 2010
Last verified: May 2010
| Tracking Information | |||||
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| First Received Date ICMJE | September 12, 2007 | ||||
| Last Updated Date | May 5, 2010 | ||||
| Start Date ICMJE | May 2007 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00529009 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Pharmacokinetic Investigation of UDCA in Bile and Serum | ||||
| Official Title ICMJE | Not Provided | ||||
| Brief Summary | To assess the bile acid composition of cystic bile and serum pharmaco¬kinetics after a 3-week treatment with UDCA and to correlate pharmacokinetic parameters of UDCA in bile and serum during steady state. |
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| Detailed Description | see protocol |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 1 | ||||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Open Label |
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| Condition ICMJE | Healthy | ||||
| Intervention ICMJE | Drug: UDCA | ||||
| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | Not Provided | ||||
| Completion Date | Not Provided | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 75 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Netherlands | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00529009 | ||||
| Other Study ID Numbers ICMJE | URT-14/BIO | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Dr. Falk Pharma GmbH | ||||
| Study Sponsor ICMJE | Dr. Falk Pharma GmbH | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Dr. Falk Pharma GmbH | ||||
| Verification Date | May 2010 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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