Study to Investigate the Relative Bioavailability of Ibuprofen in Healthy Volunteers

NCT02183012 | Completed Phase 1

• 1 other identifier: 1024.5
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

Brief Summary

• Study to demonstrate average bioequivalence between a 400 mg ibuprofen extrudate tablet (Test) and a 400 mg ibuprofen lysinate tablet (Dolormin extra ®; reference 1) under fasted conditions.
• Study to determine the relative bioavailability of ibuprofen following single administration of a 400 mg ibuprofen extrudate tablet (Test) compared to a 400 mg ibuprofen tablet (Brufen® 400mg, Denmark; Reference 2) under fasted conditions.
• Study to determine the relative bioavailability of ibuprofen following single administration of a 400 mg ibuprofen extrudate tablet (Test) compared to a 400 mg ibuprofen lysinate tablet (Dolormin extra ®; reference 1) or a 400 mg ibuprofen tablet (Brufen® 400mg, Denmark; Reference 2), respectively, under fed conditions.
• Study to evaluate the effect of food on the pharmacokinetics of ibuprofen for all three formulations.

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• AUC0-∞ (area under the concentration-time curve of the analyte in plasma from zero time to infinity)

  Pre-dose and 15, 30, 45 min, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24 hours after treatment on day 1 of visits 2-5

• Cmax (maximum observed concentration of the analyte in plasma)

  Pre-dose and 15, 30, 45 min, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24 hours after treatment on day 1 of visits 2-5

• AUC0-tz (area under the concentration-time curve of the analyte in plasma from zero time to the time of the last quantifiable drug concentration)

  Pre-dose and 15, 30, 45 min, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24 hours after treatment on day 1 of visits 2-5

Secondary Outcomes (14)

• Individual time courses of the ibuprofen plasma concentrations

  Pre-dose and 15, 30, 45 min, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24 hours after treatment on day 1 of visits 2-5

• AUCtrunc (Area under the concentration-time curve of the analyte in plasma from zero time to median tmax values of the reference formulation)

  Pre-dose and 15, 30, 45 min, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24 hours after treatment on day 1 of visits 2-5

• tmax (time to reach Cmax)

  Pre-dose and 15, 30, 45 min, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24 hours after treatment on day 1 of visits 2-5

• t1/2 (terminal half-life of the analyte in plasma)

  Pre-dose and 15, 30, 45 min, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24 hours after treatment on day 1 of visits 2-5

• λz (terminal rate constant of the analyte in plasma)

  Pre-dose and 15, 30, 45 min, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24 hours after treatment on day 1 of visits 2-5

Study Arms (6)

A: Ibuprofen extrudate, fed state

EXPERIMENTAL

Drug: Ibuprofen extrudate

B: Ibuprofen extrudate, fasted state

EXPERIMENTAL

Drug: Ibuprofen extrudate

C: Ibuprofen lysinate tablet, fed state

ACTIVE COMPARATOR

Drug: Ibuprofen lysinate

D: Ibuprofen lysinate tablet, fasted state

ACTIVE COMPARATOR

Drug: Ibuprofen lysinate

E: Ibuprofen tablet, fed state

ACTIVE COMPARATOR

Drug: Ibuprofen

F: Ibuprofen tablet, fasted state

ACTIVE COMPARATOR

Drug: Ibuprofen

Interventions

Ibuprofen extrudate DRUG

A: Ibuprofen extrudate, fed state; B: Ibuprofen extrudate, fasted state

Ibuprofen lysinate DRUG

C: Ibuprofen lysinate tablet, fed state; D: Ibuprofen lysinate tablet, fasted state

Ibuprofen DRUG

E: Ibuprofen tablet, fed state; F: Ibuprofen tablet, fasted state

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy males and females according to the following criteria:
• Based upon a complete medical history, including the physical examination, vital signs (BP, PR), 12-lead ECG, clinical laboratory tests:
• No finding deviating from normal and of clinical relevance
• No evidence of a clinically relevant concomitant disease.
• Age ≥ 21 and Age ≤ 50 years
• BMI ≥ 18.5 and BMI ≤ 29.9 kg/m2 (Body Mass Index)
• Signed and dated written informed consent prior to admission to the study in accordance with GCP (Good Clinical Practice) and the local legislation

You may not qualify if:

• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• Surgery of gastrointestinal tract (except appendectomy)
• History of recent surgery including dental surgery
• History of gastrointestinal ulcer or gastrointestinal inflammation (gastritis, ulcerative colitis, Crohn's disease)
• Blood dyscrasias of unknown origin
• Subjects with porphyries diseases
• Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
• History of relevant orthostatic hypotension, fainting spells or blackouts
• Chronic or relevant acute infections
• History of allergy/hypersensitivity/allergic rhinitis (including drug allergy) which is deemed relevant to he trial as judged by the investigator
• Intake of drugs with a long half-life (\> 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial except substitution therapy (thyroid, ovaries) and hormonal contraception
• Use of any drugs, which might influence the results of the trial (within 10 days prior to administration or during the trial)
• Participation in another trial with an investigational drug (within two months prior to administration or during the trial)
• Smoker (more than 10 cigarettes or 3 cigars or 3 pipes/day)
• Inability to refrain from smoking on trial days

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Interventions

solufenum; Ibuprofen

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2014
• First Posted: July 8, 2014
• Study Start: August 1, 2002
• Primary Completion: October 1, 2002
• Last Updated: July 8, 2014

Record last verified: 2014-07