Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04529811 | Randomised, Placebo-controlled Safety and Pharmacokinetics Study of Novel Rifaximin Formulations in Healthy Volunteers | PHASE1 | COMPLETED | 124 | — | — | Sep 24, 2020 | May 9, 2021 | Jun 18, 2021 | 1 | New Zealand |
| Arm | Type | Description |
|---|---|---|
| Formulation 1 - Low Dose | EXPERIMENTAL | Rifaximin Formulation 1 Capsules |
| Formulation 1 Capsules - Mid Dose | EXPERIMENTAL | Rifaximin Formulation 1 Capsules |
| Formulation 1 Capsules - High Dose | EXPERIMENTAL | Rifaximin Formulation 1 Capsules |
| Formulation 1 Capsules - Max Dose | EXPERIMENTAL | Rifaximin Formulation 1 Capsules |
| Formulation 1 Capsules - Placebo | PLACEBO_COMPARATOR | Placebo Formulation 1 Capsules |
| Formulation 2 - Low Dose | EXPERIMENTAL | Rifaximin Formulation 2 Capsules |
| Formulation 2- Mid Dose | EXPERIMENTAL | Rifaximin Formulation 2 Capsules |
| Formulation 2 - High Dose | EXPERIMENTAL | Rifaximin Formulation 2 Capsules |
| Formulation 2 - Max Dose | EXPERIMENTAL | Rifaximin Formulation 2 Capsules |
| Formulation 2 - Placebo | PLACEBO_COMPARATOR | Placebo Formulation 2 Capsules |
| Formulation 3 - Low dose | EXPERIMENTAL | Rifaximin Formulation 3 Capsules |
| Formulation 3 - Mid dose | EXPERIMENTAL | Rifaximin Formulation 3 Capsules |
| Formulation 3 - High dose | EXPERIMENTAL | Rifaximin Formulation 3 Capsules |
| Formulation 3 - Max dose | EXPERIMENTAL | Rifaximin Formulation 3 Capsules |
| Formulation 3 - Placebo | PLACEBO_COMPARATOR | Placebo Formulation 3 Capsules |
| Name | Type | Description |
|---|---|---|
| Rifaximin Novel Formulation | DRUG | Rifaximin Novel Formulation |
| Placebo | DRUG | Placebo |
Inclusion Criteria: * The participant has the ability and willingness to sign a written informed consent, is either male or female aged between 18 and 65 years, inclusive, at the time of informed consent, is in good general health, and has a body mass index (BMI) at least 18 kg/m2 and at most 34 kg...