Comparative assessment of the absorption of a generic formulation of 40 mg/mL posaconazole oral suspension against the innovator posaconazole oral suspension conducted under fed conditions in healthy male & female volunteers
A single dose, randomized, blinded, bioequivalence study of a test formulation of posaconazole oral suspension in a 3 way crossover comparison against the innovator posaconazole oral suspension conducted under fed conditions in healthy male & female volunteers
Zenith Technology Corp Ltd
36 participants
Sep 9, 2017
Interventional
Conditions
Summary
The objective of this study is to evaluate the bioequivalence of the test (new) formulation of 1 x 40 mg/mL posaconazole oral suspension against the reference formulation (innovator brand of 1 x 40 mg/mL posaconazole oral suspension) following oral administration of a single dose of 40mg/mL in healthy male and female subjects under fed conditions.
Eligibility
Inclusion Criteria6
- Healthy male and non-pregnant females
- Aged between 18 and 55 inclusive
- Non-smoker
- BMI between 18.5 and 30.0 inclusive
- Normal, healthy individuals as determined by medical history, physical examination, ECG, vital signs and laboratory tests
- Able to provide written informed consent
Exclusion Criteria8
- Any history of recent recurrent attacks of bronchitis, asthma, migraine headaches
- Concomitant drug therapy of any kind
- Sensitivity to posaconazole or any other similar class of medicines, or the excipients of posaconazole
- History of any conditions that might interfere with the absorption, distribution, metabolism or excretion of the drug
- History of cardiac problems or conditions
- History of alcohol or drug abuse or dependency
- Participation in a drug study within 60 days of the start of the study or donated blood in the 60 days preceding the study.
- Volunteers for whom the Clinical Investigator believes, for any reason, that participation would not be an acceptable risk
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Interventions
Single dose, crossover study design whereby each participant receives the test formulation of posaconazole (1 x 40 mg/mL) oral suspension on one occasion and the innovator formulation of posaconazole (1 x 40 mg/mL) oral suspension on two occasions with each dose seperated by a one week washout period. The intervention for this trial is the test formulation of posaconazole. No water is allowed for 1 hour prior to dosing until 1 hour after dosing (except for the water consumed with the dose). Participants are required not to eat for 10 hours prior to receiving breakfast. Subjects will be provided with a standardised high fat breakfast which they must start eating 30 minutes prior to dosing. Subjects are required to fast for approximately 4 hours after receiving each dose. Bathroom visits will be supervised to ensure no unauthorised water or food intake and for personal safety. Participants will be confined at the Clinical Site for 10 hours prior to dosing to ensure compliance. Standard meals will be consumed at the Clinical Site with no additional food intake allowed. Alcohol breath testing will be performed upon each participant reporting to the Clinical Site 10 hours prior to dosing. Pre and post study laboratory tests will be completed to assess the health of participants along with HIV, Hepatitis and drugs of abuse testing. Each dose will be administered orally through a syringe and swallowed with 240 ml of water at ambient temperature. The full amount of suspension must be swallowed and a mouth check will be conducted to ensure the medication has been taken as directed.
Locations(1)
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ACTRN12617001219370