Safety and Pharmacokinetic Effects of Oseltamivir Alone or in Combination With Amantadine - Full Text View

Sponsor:	Novartis
Collaborator:	Hoffmann-La Roche
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00416962

Purpose

This study is designed to assess the safety and pharmacokinetic effects of oseltamivir administration alone or in combination with amantadine in healthy volunteers.

Condition	Intervention	Phase
Healthy	Drug: amantadine hydrochloride Drug: oseltamivir phosphate	Phase I

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	An Open-Label, Multiple Dose, Randomized, Three-Period Crossover Study in Healthy Volunteers to Evaluate the Effect of co-Administration of Amantadine 100 mg BID and Oseltamivir 75 mg BID on the Pharmacokinetic Properties of Amantadine and Oseltamivir.

Resource links provided by NLM:

Drug Information available for: Amantadine sulfate Oseltamivir Tamiflu Amantadine hydrochloride Amantadine

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

To characterize the pharmacokinetics of amantadine following twice daily administration alone or in combination with twice daily oseltamivir in healthy volunteers.
To characterize the pharmacokinetics of oseltamivir following twice daily administration alone or in combination with twice daily amantadine in healthy volunteers.

Secondary Outcome Measures:

To assess the safety and tolerability of twice daily oseltamivir and twice daily amantadine when given alone and when given in combination.

Estimated Enrollment:	18
Study Start Date:	August 2006
Study Completion Date:	December 2006

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Healthy male or female subjects aged 18 to 45 years, and in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests
Vital signs within the following ranges:
- oral body temperature 35.0 - 37.5°C
- systolic blood pressure 90 - 140 mm Hg
- diastolic blood pressure 50 - 90 mm Hg
- pulse rate 40 - 90 bpm
Female subjects of child bearing potential must be using double-barrier local contraception (for example, intra-uterine device plus condom, or spermicidal gel plus condom) or have been surgically sterilized at least 6 months prior before study start, with supportive clinical documentation OR Postmenopausal women must have no regular menstrual bleeding for at least 1 year prior to inclusion.
Body mass index must be within 18 - 30 kg/m2. Subjects must weigh at least 50 kg.

Exclusion Criteria:

Smokers (use of tobacco products in the previous 3 months). Smokers will be defined as those who report tobacco use or have a urine cotinine greater than 500 ng/mL
Female subjects who are pregnant or lactating
Participation in any clinical investigation involving medical intervention within 4 week prior to study start.
Donation or loss of ≥ 400 mL of blood within 8 weeks prior to study start, or longer if required by local regulation.
Significant illness within 2 weeks before study start.
A past personal or close family medical history of clinically significant ECG abnormalities or of a prolonged QT-interval syndrome.
History of autonomic dysfunction (for example, history of fainting).
History of acute or chronic bronchospastic disease (including asthma and chronic obstructive pulmonary disease, treated or untreated),
History of clinically significant drug allergy or history of atopic allergy (asthma, urticaria, eczematous dermatitis). A known hypersensitivity to the study drug or to similar drugs.
Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of drugs, or which may jeopardize the subject in case of participation in the study, including bowel, gastrointestinal, renal, pancreatic, hepatic, hematological, immunological, or neurological disorders.

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00416962

Locations

United States, New Jersey
Novartis Investigative Site
East Hanover, New Jersey, United States, 07936-1080

Sponsors and Collaborators

Novartis

Hoffmann-La Roche

Investigators

Principal Investigator:

Novartis

Investigator site

More Information

No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Morrison D, Roy S, Rayner C, Amer A, Howard D, Smith JR, Evans TG. A randomized, crossover study to evaluate the pharmacokinetics of amantadine and oseltamivir administered alone and in combination. PLoS ONE. 2007 Dec 12;2(12):e1305.

ClinicalTrials.gov Identifier:	NCT00416962 History of Changes
Other Study ID Numbers:	CSYO380A2101
Study First Received:	December 27, 2006
Last Updated:	November 29, 2007
Health Authority:	United States: Institutional Review Board

Keywords provided by Novartis:

Oseltamivir, amantidine, Symmetrel, Tamiflu

Additional relevant MeSH terms:

Amantadine
Oseltamivir
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents

Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on February 12, 2012