A Study on Ketoprofen Lysine Salt (KLS) + Gabapentin (GABA) vs KLS to Investigate Their Pharmacodynamic in Healthy Males
Summary
Part A The primary objective of this study is to determine the single dose pharmacokinetics (PK) of ketoprofen lysine salt combined with gabapentin (KLS-GABA \[80 mg-34 mg\]) compared to KLS alone (80 mg) in healthy male subjects. The secondary objective of this study is: • To determine the safety and tolerability of a single oral dose of KLS-GABA (80 mg-34 mg) compared to KLS alone (80 mg) in healthy male subjects. Part B The primary objective of this study is to determine the pharmacodynamic (PD) effects of KLS-GABA in the Intradermal (ID) capsaicin model in healthy male subjects. The secondary objectives of this study are: * To further investigate the safety, tolerability, and PK of single oral doses of KLS-GABA and KLS alone. * To investigate the possible relationship between plasma levels of drug and efficacy in pain reduction.
Timeline
- Start
- 2021-02-08
- Primary completion
- 2022-03-30
- Completion
- 2022-04-25
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Gabapentin | Small molecule | 17 mg | Oral |
| Comparator | Gabapentin | Small molecule | 34 mg | Oral |
| Comparator | Gabapentin | Small molecule | 68 mg | Oral |
| Comparator | Gabapentin | Small molecule | 300 mg | Oral |
| Comparator | Ketoprofen | Small molecule | 40 mg | Oral |
| Comparator | Ketoprofen | Small molecule | 80 mg | Oral |
| Comparator | Ketoprofen | Small molecule | 160 mg | Oral |
Indications
No indication recorded.