Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
A single center, single dose, open-label, randomized, 3-period, 6-sequence, crossover study conducted in normal healthy subjects to evaluate the effect of a high- and low-fat meal on the pharmacokinetics (PK), bioavailability (BA), and safety of COV155.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COV155 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| COV155 | Drug | COV155 tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration-time curve (AUC) | To evaluate the effect of food on the pharmacokinetics and bioavailability of COV155 following administration of the formulation given as 3 tablets in healthy subjects under fasting and fed (high- and low-fat) conditions | 48 hours |
| Maximum observed plasma concentration (Cmax) | To evaluate the effect of food on the pharmacokinetics and bioavailability of COV155 following administration of the formulation given as 3 tablets in healthy subjects under fasting and fed (high- and low-fat) conditions | 48 hours |
| Time to achieve the maximum observed plasma concentration (Tmax) | To evaluate the effect of food on the pharmacokinetics and bioavailability of COV155 following administration of the formulation given as 3 tablets in healthy subjects under fasting and fed (high- and low-fat) conditions | 48 hours |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26614499 | Derived | Devarakonda K, Kostenbader K, Giuliani MJ, Young JL. Single-dose pharmacokinetics of 2 or 3 tablets of biphasic immediate-release/extended-release hydrocodone bitartrate/acetaminophen (MNK-155) under fed and fasted conditions: two randomized open-label trials. BMC Pharmacol Toxicol. 2015 Nov 27;16:31. doi: 10.1186/s40360-015-0032-y. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided