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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07110441 | Pharmacokinetic Study on G1090N (Nitazoxanide) Capsules in Healthy Volunteers | PHASE1 | COMPLETED | 52 | — | — | Aug 26, 2025 | Dec 3, 2025 | Jan 16, 2026 | 1 | United States |
To evaluate pharmacokinetics (PK) following single and multiple ascending dose administration of G1090N in healthy subjects. Plasma PK parameters will be determined for tizoxanide (TZ) and tizoxanide glucuronide (TZG) concentrations including but not limited to Cmax.
To evaluate PK following single and multiple ascending dose administration of G1090N in healthy subjects. Plasma PK parameters will be determined for TZ and TZG concentrations including but not limited to tmax.
To evaluate PK following single and multiple ascending dose administration of G1090N in healthy subjects. Plasma PK parameters will be determined for TZ and TZG concentrations including but not limited to AUC.
To evaluate PK following single and multiple ascending dose administration of G1090N in healthy subjects. Plasma PK parameters will be determined for TZ and TZG concentrations including but not limited to t1/2.
To evaluate PK following single and multiple ascending dose administration of G1090N in healthy subjects. Urine PK parameters will be determined for TZ and TZG concentrations including but not limited to Ae.
To evaluate PK following single and multiple ascending dose administration of G1090N in healthy subjects. Urine PK parameters will be determined for TZ and TZG concentrations including but not limited to CLr.
To evaluate PK following single and multiple ascending dose administration of G1090N in healthy subjects. Urine PK parameters will be determined for TZ and TZG concentrations including but not limited to fe.
| Arm | Type | Description |
|---|---|---|
| G1090N 300 mg | EXPERIMENTAL | Subjects will recieve a single dose of G1090N |
| G1090N 600 mg | EXPERIMENTAL | Subjects will recieve single and multiple doses of G1090N |
| G1090N 900 mg | EXPERIMENTAL | Subjects will recieve single and multiple doses of G1090N |
| G1090N 1200 mg | EXPERIMENTAL | Subjects will recieve single and multiple doses of G1090N |
| Name | Type | Description |
|---|---|---|
| Single Dose G1090N | DRUG | Subjects will receive single ascending doses of G1090N up to 1200mg. |
| Multiple dosing of G1090N | DRUG | Subjects will receive multiple ascending doses of G1090N up to 1200mg twice daily for 7 consecutive days. |
Inclusion Criteria: * 1\. Healthy subjects with absence of clinically relevant abnormalities as determined by the Investigator or medically qualified designee based on a detailed medical history and complete physical examination; * 2\. Clinical laboratory test results for liver and renal function w...