Conditions: Healthy Subjects
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 36
Healthy volunteers: yes

Brief summary:
This was a non-randomized, open label study in healthy male and female volunteers. A single intranasal dose of 30 mg ketorolac tromethamine was administered to all subjects on Days 1 and 6; in addition, subjects received a daily intranasal dose of 200 µg fluticasone propionate on Days 2-6. Subjects remained resident in the Clinical Unit from the evening of Day 1 until the morning of Day 2 and from the evening of Day 5 until the morning of Day 7, and made ambulatory visits to the Clinical Unit on the morning of Days 3-5. A post study medical was performed within 7 days of study completion.

The objective of this study was to assess the effects of chronic administration of fluticasone propionate on the pharmacokinetics of intranasal ketorolac in healthy male and female subjects.

Detailed description:

Arms:
arm 1: None

Interventions: intervention 1: Ketorolac tromethamine intervention 2: Fluticasone Propionate
Intervention descriptions: intervention 1: A single intranasal dose of 30 mg ketorolac tromethamine was administered to all subjects on Days 1 and 6. intervention 2: Daily intranasal dose of 200 ug fluticasone propionate on Days 2-6

Protocol document: