A pilot 2-way crossover pharmacokinetic (PK) study (Part A) followedby a pivotal 2-way crossover PK study to assess bioequivalence(Part B) between a test and reference intravenous formulations of150 mg Fosaprepitant

Phase 1

• Conditions: prevention of nausea and vomiting caused by Chemotherapy; Oral and Gastrointestinal - Normal oral and gastrointestinal development and function

• Registration Number: ACTRN12619000189123
• Lead Sponsor: evakar Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-02-11
• Study Completion: 2019-07-29
• Last Update Posted: 11 October 2021

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 37

Inclusion Criteria

Male or female aged 18 to 55 years, healthy as determined by pre-study medical history, physical examination (PE), vital signs, complete neurological examination and 12-lead electrocardiogram (ECG) confirming normal sinus rhythm;
laboratory screening tests should be within normal limits or any abnormalities should be not clinically significant. Negative screen for alcohol and drugs of abuse at screening and admission . Non-smokers or ex-smokers (must have ceased smoking >3 months prior screening visit);
Female participants:
Must be of non-child-bearing potential OR must not be pregnant, breast feeding, or planning to become pregnant

Exclusion Criteria

Have a clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary,immunological, dermatological, endocrine, connective tissue diseases or disorders. Have a history of severe drug allergy, or hypersensitivity or severe food allergy
Consume more than 21 units of alcohol a week 6. Have used any investigational drug or participated in any clinical trial within 30 days prior to screening. Have donated or received any blood or blood products within the 3 months prior to screening;
Are unlikely to co-operate with the requirements, including duration of admission to the
study and expected follow up visit. Are unwilling or unable to give written informed consent. Have blood coagulation test results (prothrombin time (PT), activated partial thromboplastin time (APTT)) that are outside of the normal range.

Study & Design

• Study Type: Interventional
• Study Design: Not specified