Pharmacokinetics Clinical Trial
Official title:
An Open-label, Single-dose, Randomised, Crossover Study to Evaluate Changes in the Pharmacokinetics of Ibuprofen From Ibuprofen-LDH Dosed With and Without Release Modifying Excipients in Normal, Healthy, Adult Subjects
| Verified date | May 2017 |
| Source | Oxford Pharmascience Ltd |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This study is to help development of a new version of Ibuprofen, called Ibuprofen-LDH.
Ibuprofen-LDH will be used as a treatment for muscular pains, headache, fever etc. This new
version of ibuprofen is expected to produce fewer stomach/intestine related side effects
when compared to many existing marketed formulations of Ibuprofen.
This study is split into 3 parts. Part A is a 7 way crossover, Part B is a maximum of a 6
way crossover and Part C is a maximum of a 4 way crossover. The size of Parts B & Part C and
allocated interventions will be confirmed after review of data from Parts A and/or B
respectively.
A total of 30 subjects will take part in the study; 10 per study part.
The key objective is to assess the pharmacokinetics properties of Ibuprofen-LDH, with and
without a selection of different excipients. The pharmacokinetic properties will include how
quickly the drug is absorbed into the bloodstream and also the maximum concentration of drug
that reaches the bloodstream.
| Status | Completed |
| Enrollment | 30 |
| Est. completion date | May 3, 2017 |
| Est. primary completion date | April 28, 2017 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 55 Years |
| Eligibility |
Inclusion Criteria: - Healthy male or female subjects - BMI 18 - 30 kg/m2 - Willing and able to provide written informed consent Exclusion Criteria: - Evidence or history of significant renal, hepatic, gastrointestinal, central nervous system, respiratory, cardiovascular, autoimmune or metabolic dysfunction - Recent or concurrent use of prescription or non-prescription medications, other than contraceptives - Allergy or sensitivity to NSAIDs |
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | Simbec Orion Ltd | Merthyr Tydfil |
| Lead Sponsor | Collaborator |
|---|---|
| Oxford Pharmascience Ltd |
United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Cmax | 12 hours | ||
| Primary | AUC(0-inf) | 12 hours |
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