Single-Dose Bioavailability Study of Two Formulations of Ibuprofen and Pseudoephedrine Hydrochloride Tablets

NCT03429738 | Completed Phase 1

• 1 other identifier: PMRI study number 2014-3489
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluation of the comparative bioavailability between two oral formulations containing ibuprofen 200 mg and pseudoephedrine 30 mg after a single dose in healthy subjects under fasting conditions.

Conditions

Pain, Head; Pain, Acute; Pain, Back; Fever

Keywords

Ibuprofen; phase-I-study; pharmacokinetic; combination therapy; bioavailability; bioequivalence; pseudoephedrine hydrochloride

Outcome Measures

Primary Outcomes (2)

• AUC(0-t) (area under the analyte concentration versus time curve) of ibuprofen and pseudoephedrine, respectively

  The 90% confidence intervals of the relative mean plasma (1S,2S)- pseudoephedrine and (S) ibuprofen AUC should be between 80.00 and 125.00%

  7 days (± 3 hours)

• maximum serum concentration of ibuprofen and pseudoephedrine, respectively

  The 90% confidence intervals of the relative mean plasma (1S,2S)- pseudoephedrine and (S) ibuprofen Cmax should be between 80.00 and 125.00%

  7 days (± 3 hours)

Study Arms (2)

Experimental Drug

EXPERIMENTAL

Drug: Ibuprofen/Pseudoephedrine HCl 200/30 mg Film-Coated Tablets Temmler Werke GmbH/ Part of Aenova Group, Germany, Intervention: one tablet administered after an overnight fast of at least 10 hours

Drug: Ibuprofen/Pseudoephedrine HCl 200/30 mg Film-Coated Tablets

Active Comparator

ACTIVE COMPARATOR

Active Comparator: RhinAdvil Rhume 200 mg/30 mg Film-Coated Tablets Wyeth Santé Familiale, France, Intervention: one tablet administered after an overnight fast of at least 10 hours

Drug: RhinAdvil Rhume 200 mg/30 mg Film-Coated Tablets

Interventions

Ibuprofen/Pseudoephedrine HCl 200/30 mg Film-Coated Tablets DRUG

Experimental drug

Also known as: Ibuprofen/Pseudoephedrine/test product

Experimental Drug

RhinAdvil Rhume 200 mg/30 mg Film-Coated Tablets DRUG

Active Comparator

Also known as: RhinAdvil

Active Comparator

Eligibility Criteria

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

You may qualify if:

• Healthy, non-smoking, male and female subjects, 18 years of age or older.
• BMI ≥ 18.5 and 30.0 kg/m2
• No clinically significant findings in vital signs measurements.
• No clinically significant abnormal laboratory values.
• No clinically significant findings in a 12-lead electrocardiogram (ECG).
• No significant diseases.
• Willing to use an acceptable, effective method of contraception.
• Be informed of the nature of the study and give written consent prior to any study procedure.
• Have no clinically significant findings from a physical examination.

You may not qualify if:

• Known history or presence of any clinically significant medical condition.
• Known or suspected carcinoma.
• History or presence of ulcerative colitis, diverticulosis, Crohn's disease, or gastrointestinal ulcer, perforation, or haemorrhage.
• Known history or presence of auto-immune disorders, gastrointestinal toxicity, or a risk of gastrointestinal bleeding or gastrointestinal tract irritation.
• Known history or presence of cardiovascular disease, heart failure, tachycardia, hypertension, angina pectoris, hyperthyroidism, psychosis, seizures, risk of urinary retention, diabetes, phaeochromocytoma, closed angle glaucoma, chronic rhinitis, or prostatic enlargement.
• Known history or presence of angioedema.
• Known history or presence of galactose or fructose intolerance, sucraseisomaltase insufficiency, Lapp lactase insufficiency, galactosemia, or glucose-galactose malabsorption syndrome.
• Known history of severe skin reactions (e.g. exfoliative dermatitis, SJS, and TEN).
• Known history or presence of bronchial asthma or allergic disease resulting in bronchospasm.
• Presence of hepatic or renal dysfunction.
• Presence of clinically significant gastrointestinal disease or history of malabsorption within the last year.
• Presence of a medical condition requiring regular medication (prescription and/or over-the-counter) with systemic absorption.
• History of drug or alcohol addiction requiring treatment.
• History of gastrointestinal bleeding or perforation when previously taking NSAIDs.
• Positive test result for HIV, Hepatitis B surface antigen or Hepatitis C antibody.

Sponsors & Collaborators

• Institut für Pharmakologie und Präventive Medizin: lead
• Pharma Medica Research, Inc.: collaborator

Study Sites (1)

Pharma Medica Research Inc.

Toronto, Ontario, MIS 3V6, Canada

Location

MeSH Terms

Conditions

Headache; Acute Pain; Back Pain; Fever

Interventions

Ibuprofen; Pseudoephedrine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Temperature Changes

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Propanolamines; Amino Alcohols; Alcohols; Propanols; Amines; Phenethylamines; Ethylamines

Study Officials

• Latifa Yamlahi, MD

  Pharma Medica Research, Inc.

  STUDY DIRECTOR

Study Design

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

Model Details: open-label, single-dose, randomized, two-period, two-treatment, twosequence, crossover, comparative bioavailability study.

Study Record Dates

• First Submitted: January 31, 2018
• First Posted: February 12, 2018
• Study Start: April 27, 2014
• Primary Completion: May 5, 2014
• Study Completion: May 5, 2014
• Last Updated: February 12, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)