A Study on Ketoprofen Lysine Salt (KLS) + Gabapentin (GABA) vs KLS to Investigate Their Pharmacodynamic in Healthy Males
Status:
Recruiting
Trial end date:
2022-04-10
Target enrollment:
Participant gender:
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.