NCT03767036

Administration of Tramadol and Ketorolac Separately and Simultaneously to Assess a Potential Pharmacokinetic Interaction

Single Site Pharmacokinetic Non-interaction Study With Open-label, Randomized, Single-dose, Three-period, Six-sequence, Crossover Design to Compare Tramadol Hydrochloride 25 mg Capsules (Tradol [Trade Mark], Product of Grünenthal Mexico S.A. de C.V.) and Ketorolac Tromethamine 10 mg Tablets (Dolac [Trade Mark], Product of Siegfried Rhein, S.A. de C.V.) Administered Separately and Simultaneously in Healthy Volunteers Under Fasting Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Grünenthal GmbH · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

Tramadol (Tradol) and ketorolac (Dolac) are marketed products to treat acute pain. This study was performed to determine if both medications can be given to a patient simultaneously without a change of the products' bioavailability.

Detailed description

The primary objective of the study was to compare the bioavailability of tramadol 25 mg and ketorolac 10 mg after oral single-dose administration of the individual components, either separately or simultaneously, in healthy volunteers under fasting conditions, to demonstrate the absence of a pharmacokinetic interaction. The secondary objective of the study was to evaluate the safety of both drugs when administered separately and simultaneously based on adverse events reported after treatment. Participants were admitted to the study site for approximately 42 hours (12 hours before and 30 hours after dosing) for each of the 3 treatment periods. A final examination was performed 2 days after completion of the last treatment period.

Conditions

• Pharmacokinetics

Interventions

Type	Name	Description
DRUG	Tramadol hydrochloride 25 mg capsule	Capsule with tramadol hydrochloride 25 mg; Product of Grünenthal de Mexico S.A. de C.V.
DRUG	Ketorolac Tromethamine 10 mg tablet	Tablet with ketorolac tromethamine 10 mg; Product of Siegfried Rhein, S.A. de C.V., Mexico

Timeline

• Start date: 2017-06-05
• Primary completion: 2017-06-28
• Completion: 2017-06-30
• First posted: 2018-12-06
• Last updated: 2018-12-11

Locations

1 site across 1 country: Mexico