Recent Updates
Recently added Catalysts

rimantadine

Phase 1

Healthy Volunteer | Small molecule | Other |Roche Holding AG|Last Updated: Aug 19, 2016

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment24

FDA Designations

No designations recorded

Clinical trial landscape

rimantadine · 1 trial · 1 indication

Phase 1 1
NCT01172847A Pharmacokinetic Study on Co-administration of Tamiflu (Oseltamivir) and Rimantadine in Healthy VolunteersHealthy Volunteer
COMPLETED24 Analytics
PHASE1COMPLETED
A Pharmacokinetic Study on Co-administration of Tamiflu (Oseltamivir) and Rimantadine in Healthy Volunteers
Healthy VolunteerUnlock trial analytics

Study Endpoints

Primary Endpoints

Steady State Area Under the Plasma Concentration Versus Time Curve From 0 to 12 Hours After Dosing (AUC0-12) of Oseltamivir and Oseltamivir Carboxylate
Pre-dose; 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours post-dose on Day 5

Oseltamivir carboxylate is active metabolite of oseltamivir. AUC0-12 of oseltamivir and oseltamivir carboxylate were calculated following the administration of oseltamivir alone or in combination with rimantadine, using the linear trapezoidal rule.

Steady State Area Under the Plasma Concentration Versus Time Curve From 0 to 12 Hours After Dosing (AUC0-12) of Rimantadine
Pre-dose; 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours post-dose on Day 5

AUC0-12 of rimantadine was calculated following the administration of rimantadine alone or in combination with oseltamivir, using the linear trapezoidal rule.

Secondary Endpoints

Maximum Plasma Concentration (Cmax) of Oseltamivir and Oseltamivir Carboxylate
Pre-dose; 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours post-dose on Day 5
Maximum Plasma Concentration (Cmax) of Rimantadine
Pre-dose; 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours post-dose on Day 5
Number of Participants With Any Adverse Events (AEs) and Any Serious Adverse Events (SAEs)
Up to 11 weeks
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER

Treatment Arms

ArmTypeDescription
AACTIVE_COMPARATOR -
BACTIVE_COMPARATOR -
CEXPERIMENTAL -

Interventions

NameTypeDescription
oseltamivir [Tamiflu]DRUGmultiple oral doses
rimantadineDRUGmultiple oral doses
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 45 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Adults, aged 18 to 45 years * Healthy as judged by general physical examination, medical history, vital signs, 12-lead ECG and laboratory tests * Body Mass Index (BMI) 18-34 kg/m2 * Willing not to participate in any other trial including an investigational drug for 3 months fo...

Countries:United States
Unlock Eligibility Criteria

Frequently asked questions about rimantadine

What is rimantadine used for?

Rimantadine is a small molecule drug being studied for use in healthy volunteers. It is currently in Phase 1 clinical development. The drug is being investigated in a pharmacokinetic study to assess its interaction when co-administered with oseltamivir.

Who makes rimantadine?

Rimantadine is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting clinical research on this small molecule drug, which is currently in Phase 1 development for use in healthy volunteers.

What phase is rimantadine in?

Rimantadine is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The drug is being studied in healthy volunteers to evaluate its pharmacokinetic properties when taken with oseltamivir.

What clinical trials is rimantadine in?

Rimantadine has one completed clinical trial, NCT01172847, titled 'A Pharmacokinetic Study on Co-administration of Tamiflu (Oseltamivir) and Rimantadine in Healthy Volunteers.' This Phase 1 study enrolled 24 participants in the United States and was active-controlled.

Is rimantadine the same as oseltamivir?

No, rimantadine is not the same as oseltamivir. Rimantadine is a separate investigational drug being studied in combination with oseltamivir, which is marketed as Tamiflu. The clinical trial NCT01172847 evaluates the pharmacokinetics of co-administering these two different drugs.