A Study of Whether 2 New Oral Formulations of a Strong Pain Killer Release the Same Amount of Drug Into the Body as the Marketed Medication
- Conditions
- Pain
- Interventions
- Drug: Active comparator MR2XXXDrug: MR1XXXDrug: MRXXXDrug: MRXXX and MR1XXX
- Registration Number
- NCT02089581
- Lead Sponsor
- Mundipharma Research Limited
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 32
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Drug Active comparator MR2XXX MR2XXX MR1XXX MR1XXX MR1XXX capsule, 12 hourly MRXXX MRXXX MRXXX capsule 12 hourly Experimental MRXXX and MR1XXX Experimental Fed
- Primary Outcome Measures
Name Time Method Assess the pharmacokinetics and potential for bioequivalence of two novel formulations 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 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 Outcome Measures
Name Time Method 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 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
Trial Locations
- Locations (1)
Biokinetic
🇬🇧Belfast, United Kingdom