An Open-label, Randomised, Crossover, Single-dose, Study in Healthy Subjects to Compare the Pharmacokinetics of Two Formulations of a Strong Pain Killer With a Marketed Reference Product in a Fasted or Fed State
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Mundipharma Research Limited
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- Assess the pharmacokinetics and potential for bioequivalence of two novel formulations
Study Overview
Brief Summary
To determine whether two new oral formulations of a strong pain killer release the drug into the body in a similar pattern as the already marketed reference capsule formulation with or without food.
Detailed Description
Comparisons will be made between two new oral formulations and an existing marketed reference capsule formulation to determine whether the release rates of the products are similar or equivalent in a fed or fasted state. Determination is by measurement of drug concentrations in the blood at serial collection time points pre-dose until 32 hours post-dose, following an administration of a single oral dose. Pharmacokinetics parameters of AUC and Cmax are the primary endpoints.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Drug
MR2XXX
Intervention: Active comparator MR2XXX (Drug)
MRXXX
MRXXX capsule 12 hourly
Intervention: MRXXX (Drug)
MR1XXX
MR1XXX capsule, 12 hourly
Intervention: MR1XXX (Drug)
Experimental
Experimental Fed
Intervention: MRXXX and MR1XXX (Drug)
Outcomes
Primary Outcomes
Assess the pharmacokinetics and potential for bioequivalence of two novel formulations
Time Frame: Up to 32 hours
Areas under the plasma concentration-time curve calculated to the last measurable concentration (AUCt) will be calculated using the linear trapezoidal method. Where possible, the terminal phase rate constants will be estimated using those points determined to be in the terminal log-linear phase. Half-lives (t1/2Z) will be determined from the ratio of ln 2 to LambdaZ. The areas under the plasma concentration-time curve between the last measured point and infinity will be calculated from the ratio of the final observed plasma concentration (Clast) to LambdaZ. This will be added to the AUCt to yield the area under the plasma concentration-time curve between the time of administration and infinity (AUCINF).
The primary objective of the definitive phase is to assess bioequivalence of one or two experimental capsule formulations
Time Frame: 32 hours
Areas under the plasma concentration-time curve calculated to the last measurable concentration (AUCt) will be calculated using the linear trapezoidal method. Where possible, the terminal phase rate constants will be estimated using those points determined to be in the terminal log-linear phase. Half-lives (t1/2Z) will be determined from the ratio of ln 2 to LambdaZ. The areas under the plasma concentration-time curve between the last measured point and infinity will be calculated from the ratio of the final observed plasma concentration (Clast) to LambdaZ. This will be added to the AUCt to yield the area under the plasma concentration-time curve between the time of administration and infinity (AUCINF). Drug Concentration Measurements: Pre-dose on the first day of each study period, and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, 24 and 32 hours after dosing (19 samples per study period).
Secondary Outcomes
- Assess the safety and tolerability of two experimental formulations of Tablet and Capsule in a fasted and fed state by the collection of adverse events, vital signs, clinical laboratory results and ECGs(Up to 32 hours)