None listed
Conditions
Brief summary
The objective of this pilot study is to estimate the intrasubject variability and to compare the bioavailability of aprepitant from Aprepitant 130 mg Injection (InnoPharma, Inc.), EMEND Registered Trademark 150 mg Injection (Merck Sharp & Dohme Corp.) and EMEND Registered Trademark 125 mg Capsules (Merck Sharp & Dohme Corp.) in healthy, non-smoking male and female volunteers under fasting conditions.
Interventions
Arm 1: Aprepitant 130 mg IV Injection (InnoPharma, Inc.); International Non-Proprietary Name is Aprepitant injection; single dose only. At least a 10-hour overnight fasting period, subjects will be dosed and will be required to continue to fast for at least 4 hours after drug administration.
Arm 2: EMEND Registered Trademark 150 mg IV Injection (Merck Sharp & Dohme Corp.); International Non-Proprietary Name is Aprepitant injection; single dose only. At least a 10-hour overnight fasting period,
Arm 1: Aprepitant 130 mg IV Injection (InnoPharma, Inc.); International Non-Proprietary Name is Aprepitant injection; single dose only. At least a 10-hour overnight fasting period, subjects will be dosed and will be required to continue to fast for at least 4 hours after drug administration. Arm 2: EMEND Registered Trademark 150 mg IV Injection (Merck Sharp & Dohme Corp.); International Non-Proprietary Name is Aprepitant injection; single dose only. At least a 10-hour overnight fasting period, subjects will be dosed and will be required to continue to fast for at least 4 hours after drug administration. Arm 3: EMEND Registered Trademark 125 mg Oral Capsules (Merck Sharp & Dohme Corp.); International Non-Proprietary Name is Aprepitant Capsule; single dose only. At least a 10-hour overnight fasting period, subjects will be dosed and will be required to continue to fast for at least 4 hours after drug administration. Washout period is 7 days between each dosing. Subjects will be confined in the clinical facility from 10 hours prior to drug administration until 24 hours after drug administration for each study period to monitor adherence to treatment. At least a 10-hour overnight fasting period, subjects will be dosed and will be required to continue to fast for at least 4 hours after drug administration. Following a fasting period of at least 4-hours after drug administration, subjects will be given standardized meals and caffeine/methylxanthine-free beverages at scheduled times. In this study, meals will be served at approximately 4.5, 9.5 and 13.5 hours after drug administration.
Sponsors
InnoPharma, Inc.
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Healthy male and female; non-smoking; BMI that is within 18.5-29.9 kg/m^2, inclusive; Systolic blood pressure between 95-140 mmHg, inclusive, and diastolic blood pressure between 55-90 mmHg, inclusive, and heart rate between 50-100 bpm, inclusive; Ability to fast for at least 14 hours and consume standard meal; Availability to volunteer for the entire study duration and willing to adhere to all protocol requirements.
Exclusion criteria
Individuals who have participated in another clinical trial or who received an investigational drug within 30 days prior to first drug administration; Consumption of food or beverages containing caffeine/methylxanthines, poppy seeds and/or alcohol within 48 hours before dosing and containing grapefruit and/or pomelo within 10 days prior to first drug administration; Use of any prescription medication within 14 days prior to first drug administration
Outcome results
None listed