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Safety and Pharmacokinetic Effects of Oseltamivir Alone or in Combination With Amantadine

Information source: Novartis
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: amantadine hydrochloride (Drug); oseltamivir phosphate (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Novartis, Principal Investigator, Affiliation: Investigator site

Summary

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

Clinical Details

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.

Study design: Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Pharmacokinetics Study

Primary outcome:

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

Eligibility

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Both.

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

Locations and Contacts

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

Starting date: August 2006
Ending date: December 2006
Last updated: November 29, 2007

Page last updated: June 20, 2008

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