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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01224587 | Magnetic Marker Monitoring (MMM) Study With Gel Matrix Tablets Under Fasting and Fed Conditions | PHASE1 | COMPLETED | 5 | — | — | Oct 1, 2010 | Nov 1, 2010 | Nov 4, 2010 | 1 | Germany |
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | D1000078 placebo gel matrix tablet marked with approx. 5 mg Fe3O4(E172),AstraZeneca,Mölndal, Sweden , under fasting condition |
| 2 | EXPERIMENTAL | D1000082 placebo gel matrix tablet marked with approx. 5 mg Fe3O4(E172), AstraZeneca,Mölndal, Sweden, under fasting condition |
| 3 | EXPERIMENTAL | D1000083 placebo gel matrix tablet marked with approx. 5 mg Fe3O4(E172), AstraZeneca,Mölndal, Sweden ,under fasting condition |
| 4 | EXPERIMENTAL | D1000085 placebo gel matrix tablet marked with approx. 5 mg Fe3O4(E172), AstraZeneca,Mölndal, Sweden , under fasting condition |
| 5 | EXPERIMENTAL | D100083 marked with approx. 5 mg Fe3O4(E172), AstraZeneca,Mölndal, Sweden, under fed condition |
| 6 | EXPERIMENTAL | D1000085 placebo gel matrix tablet marked with approx. 5 mg Fe3O4(E172), AstraZeneca, Mölndal, Sweden , under fed condition |
| Name | Type | Description |
|---|---|---|
| D1000078 | DRUG | Oral, one single dose |
| D1000082 | DRUG | Oral, one single dose |
| D1000083 | DRUG | Oral, one single dose |
| D1000085 | DRUG | Oral, one single dose |
Inclusion Criteria: * Ethnic origin: Caucasian * Body-mass index (BMI): ≥ 19 kg/m² and ≤ 27 kg/m² * Good health * Written informed consent, after having been informed about benefits and potential risks of the trial Exclusion Criteria: * Diseases which could influence the gastric emptying and gast...