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
The purpose of this study is to assess the effects of age, weight, and body composition on the pharmacokinetic profile, safety, and tolerability of intravenous diclofenac sodium (DIC075V) in adult volunteers.
This study is an open label, single center, single-dose study to assess the effects of age, weight, and body composition on the pharmacokinetic profile, safety, and tolerability of intravenous diclofenac sodium (DIC075V) in adult volunteers. This study will be conducted in two cohorts. The first cohort of subjects will be selected based on body mass index (BMI) and weight criteria. The second cohort of subjects will be selected based on age.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Low dose Diclofenac |
|
| B | Experimental | High dose Diclofenac |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravenous diclofenac sodium (DIC075V) | Drug | High dose Diclofenac |
| |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the effects of age, weight, and body composition on the pharmacokinetic profile, safety, and tolerability of intravenous diclofenac sodium (DIC075V) in adult volunteers. | 24 hours |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| D. Ronald Goldwater, MD | Parexel | Principal Investigator |
| William Gerson, D.O. | Comprehensive Phase One | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Comprehensive Phase One | Miramar | Florida | 33025 | United States | ||
| PAREXEL International |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Intravenous diclofenac sodium (DIC075V) |
| Drug |
Low Dose Diclofenac |
|
| Baltimore |
| Maryland |
| 21225 |
| United States |