NCT04802967View on ClinicalTrials.gov

A Study on Ketoprofen Lysine Salt (KLS) + Gabapentin (GABA) vs KLS to Investigate Their Pharmacodynamic in Healthy Males

PHASE1CompletedINTERVENTIONAL
Enrollment

141

Participants

Timeline

Start Date

February 8, 2021

Primary Completion Date

March 30, 2022

Study Completion Date

April 25, 2022

Conditions
No Condition
Interventions
DRUG

Ketoprofen Lysine Salt combined with Gabapentin

KLS-GABA (80 mg-34 mg) in Part A and KLS-GABA (40 mg-17 mg or 80 mg-34 mg or 160 mg-68 mg) in Part B

DRUG

Ketoprofen Lysine Salt

KLS (80 mg) alone in each treatment period in Part A and KLS alone (40 mg, 80 mg, or 160 mg) in Part B

DRUG

Gabapentin

300 mg

OTHER

Placebo

2 capsules to maintain the blind

Trial Locations (1)

M13 9NQ

MAC Clinical Research Early Phase Unit, Manchester

All Listed Sponsors
lead

Dompé Farmaceutici S.p.A

INDUSTRY

NCT04802967 - A Study on Ketoprofen Lysine Salt (KLS) + Gabapentin (GABA) vs KLS to Investigate Their Pharmacodynamic in Healthy Males | Biotech Hunter | Biotech Hunter