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NCT00743912
A Phase 1, Single Arm, Open-Label Study to Evaluate the Effect of Rifaximin 550 MG Tablets TID on the Pharmacokinetics of Orally Administered Midazolam in Healthy Male and Female Volunteers
Phase 1 trial testing rifaximin in Pharmacokinetic in 24 participants. Completed in 1 November 2008.
1 October 2008
Quick facts
| Lead sponsor | Bausch Health Americas, Inc. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | other |
| Enrollment | 24 |
| Start date | 1 September 2008 |
| Primary completion | 1 October 2008 |
| Estimated completion | 1 November 2008 |
Drugs / interventions tested
- rifaximin (rifaximin) — full drug profile →
Conditions studied
- Pharmacokinetic — all drugs for Pharmacokinetic →
Sponsor
Bausch Health Americas, Inc. — full company profile →
Who can join
Adults 18 to 45, any sex, with Pharmacokinetic. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Individual midazolam and rifaximin plasma concentrations and pharmacokinetic parameters will be summarized.
Time frame: 21 to 38 days (including a 21 day screening period)
Sponsor's own description
The primary objective of this study is to determine if rifaximin, administered daily has an effect on the cytochrome P450 (CYP) isoenzyme 3A4, by examining any changes in the pharmacokinetics of midazolam (a CYP3A4 substrate), when co-administered.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT00743912
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Bausch Health Americas, Inc. trials
Trials by the same sponsor.
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- NCT05098028 — Pharmacokinetics and Pharmacodynamics of Rifaximin Novel Formulations in Patients With Sickle Cell Disease · Phase 2 · completed
- NCT05027282 — Safety and Effectiveness of the CLEAR + BRILLIANT TOUCH(R) Diode Laser 1440-nm and 1927-nm Combination Wavelength Treatm · NA · completed
- NCT05132231 — Canadian Real World Evidence Study of Brodalumab in Plaque Psoriasis to Understand the Impact on Quality of Life and Wor · active not recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00743912 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Bausch Health Americas, Inc.
- Last refreshed: 26 November 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00743912.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing