A Single-Dose, Randomized, Open-Label, Crossover, Pilot, Comparative Bioavailability Study of Aprepitant 130 mg Injection Versus EMEND Registered Trademark 150 mg Injection and EMEND Registered Trademark 125 mg Capsules in Healthy Male and Female Volunteers under Fasting Conditions.

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2014
INTERVENTION: 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. CONDITION: Emesis PRIMARY OUTCOME: 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. SECONDARY OUTCOME: nil 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.
Epistemonikos ID: b807b03e72280a9ffce2b03335e02859b344d4ea
First added on: Aug 23, 2024