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| ID | Type | Description | Link |
|---|---|---|---|
| MEBENDAZOLGAI1002 | Other Identifier | Janssen Research & Development, LLC |
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The purpose of the study is to evaluate the effect of food on the bioavailability (how much medication is in your blood) of mebendazole from a single 500 mg oral dose of a fast-disintegrating chewable tablet formulation of mebendazole in healthy adult participants.
This is an open-label (the participant and the study physician know what the participant is getting), randomized (like the flip of a coin), single-center, single-dose, 2-way crossover (method used to switch participants from one treatment arm to another in a clinical study) study in approximately 16 healthy adult participants. Participants will receive study medication under fed state first and later under fasted state or vice versa. The study consists of 3 phases: screening phase of approximately 3 weeks, an open-label treatment phase consisting of two 6-day treatment periods (Treatment period 1 and 2) with a 7- to 10 day washout between Day 1 of each treatment period, and a safety follow-up phase occurring 7 to 10 days after the last study-related procedure on Day 5 of Treatment Period 2. The study physician will check participant's general health during the study. Total duration of study for each participant will be approximately 48 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Sequence AB | Experimental | A single 500 mg dose of mebendazole fast-disintegrating chewable tablet will be administrated under fasted condition (Treatment A) in Treatment Period 1; In Treatment Period 2, the same medication will be administrated under fed condition (Treatment B). |
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| Treatment Sequence BA | Experimental | A single 500 mg dose of mebendazole fast-disintegrating chewable tablet will be administrated under fed condition (Treatment B) in Treatment Period 1; In Treatment Period 2, the same medication will be administrated under fasted condition (Treatment A). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mebendazole - fasted state (Treatment A) | Drug | Participants will receive a single 500 mg dose of mebendazole fast-disintegrating chewable tablet in the fasted condition. |
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| Measure | Description | Time Frame |
|---|---|---|
| Concentration of mebendazole in blood and urine under fed and fasted condition | Up to Day 5 of in each treatment period |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events | From screening up to 7 to 10 days after Day 5 of Treatment Period 2 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Merksem | Belgium |
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| Mebendazole - fed state (Treatment B) | Drug | Participants will receive a single 500 mg dose of mebendazole fast-disintegrating chewable tablet in the fed condition. |
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| ID | Term |
|---|---|
| D008463 | Mebendazole |
| ID | Term |
|---|---|
| D002219 | Carbamates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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