Ibuprofen Bioavailability Trial With Oral Single Dose Administration.

NCT03018015 | Completed Phase 1

• 1 other identifier: 1325ib16ct
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The present study will be conducted in order to assess bioequivalence of the Test product (Ibuprofen 400 mg oral powder) and the Reference product 1 (Brufen 400 mg film-coated tablet), an approved market product in the European Union. Testing for bioequivalence will be performed considering AUC0-tlast and Cmax obtained after oral single dose fasted administration of ibuprofen. In addition to the conventional immediate release tablet used as Reference 1, a soft capsule formulation will be applied as Reference 2 (Spalt Forte 400 mg Weichkapseln), as an example for a product with a very fast absorption rate. All 3 immediate release preparations contain 400 mg ibuprofen.

Conditions

Bioequivalence

Keywords

Bioequivalence; Healthy; Bioavailability; Ibuprofen

Outcome Measures

Primary Outcomes (2)

• Area under the plasma concentration versus time curve (AUC0-tlast) for ibuprofen

  16 hours interval

• Peak Plasma Concentration (Cmax) for ibuprofen

  16 hours interval

Secondary Outcomes (1)

• Number of participants with treatment-related adverse events

  from first dose until discharge of the subject (approx. 2 weeks)

Study Arms (3)

Ibuprofen 400 mg oral powder

EXPERIMENTAL

oral fasted administration of 1 sachet of Ibuprofen 400 mg oral powder (Hermes Arzneimittel GmbH, Germany), containing 400 mg ibuprofen

Drug: Ibuprofen 400 mg oral powder

Brufen 400 mg film-coated tablets

ACTIVE COMPARATOR

oral fasted administration of Brufen 400 mg film-coated tablets (Abbott Scandinavia AB, Sweden), containing 400 mg ibuprofen

Drug: Ibuprofen 400 mg film-coated tablet

Spalt forte 400 mg Weichkapseln

ACTIVE COMPARATOR

oral fasted administration of Spalt forte 400 mg Weichkapseln (Pfizer Consumer Healthcare GmbH, Germany), containing 400 mg ibuprofen

Drug: Ibuprofen 400 mg soft capsule

Interventions

Ibuprofen 400 mg oral powder DRUG

Ibuprofen 400 mg oral powder

Ibuprofen 400 mg film-coated tablet DRUG

Brufen 400 mg film-coated tablets

Ibuprofen 400 mg soft capsule DRUG

Spalt forte 400 mg Weichkapseln

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• sex: male/female
• ethnic origin: Caucasian
• age: 18 years or older
• body-mass index (BMI): ≥ 18.5 kg/m² and ≤ 30.0 kg/m², body weight \> 40 kg
• good state of health
• non-smoker or ex-smoker for at least 3 months
• written informed consent, after having been informed about benefits and potential risks of the clinical trial, as well as details of the insurance taken out to cover the subjects participating in the clinical trial

You may not qualify if:

• existing cardiac and/or haematological diseases or pathological findings, which might interfere with the safety or tolerability of the active ingredient
• existing hepatic and/or renal diseases or pathological findings, which might interfere with the safety or tolerability, and/or pharmacokinetics of the active ingredient
• existing gastrointestinal diseases or pathological findings, which might interfere with the safety, tolerability, absorption and/or pharmacokinetics of the active ingredient
• history of gastrointestinal bleeding or perforation, related to previous NSAID therapy
• existing, or history of, recurrent gastrointestinal ulcer/ bleeding
• conditions involving an increased tendency to bleeding
• active or known inflammatory bowel diseases (e.g. colitis ulcerosa, Crohn´s disease)
• history of relevant CNS and/or psychiatric disorders and/or currently treated CNS and/or psychiatric disorders
• known allergic reactions to the active ingredients used or to constituents of the pharmaceutical preparations
• history of hypersensitivity reactions (e.g. bronchial spasm, asthma, rhinitis, urticaria, or angioedema) after intake of acetylsalicylic acid or other NSAIDs
• subjects with severe allergies or multiple drug allergies unless it is judged as not relevant for the clinical trial by the investigator
• existing, or history of, bronchial asthma, chronic rhinitis or allergic diseases unless it is judged as not relevant for the clinical trial by the investigator
• subjects with hereditary problems of galactose intolerance, lactase deficiency or glucose-galactose malabsorption
• systolic blood pressure \< 90 or \> 145 mmHg
• diastolic blood pressure \< 60 or \>90 mmHg

Sponsors & Collaborators

• SocraTec R&D GmbH: lead
• SocraMetrics GmbH: collaborator

Study Sites (1)

SocraTec R&D GmbH Clinical Pharmacology Unit

Erfurt, Thuringia, 99084, Germany

Location

MeSH Terms

Interventions

Ibuprofen; Powders

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Cornelius Koch, MD

  SocraTec R&D GmbH, Clinical Pharmacology Unit

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 10, 2017
• First Posted: January 11, 2017
• Study Start: September 1, 2016
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: January 11, 2017

Record last verified: 2017-01

Locations

DE (1)