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

ID: NCT03429738
Status: Completed
Phase: Phase 1
Start Date: April 27, 2014
First Submitted: January 31, 2018
Last Updated: February 09, 2018
Results: N/A
Sponsors & Collaborators: Institut für Pharmakologie und Präventive Medizin, Pharma Medica Research, Inc.
Location: Canada
Conditions: Pain, Head, Pain, Acute, Pain, Back, Fever
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Study Description

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.

Detailed Description

Ibuprofen is one of the most often used non steroidal antiinflammatory drug (NSAR) in the management of mild to moderate pain and inflammation. Combined with the sympathomimetic pseudoephedrine as decongestant it is widely used in colds or fever. The purpose of this phase-I-study was to evaluate the comparative bioavailability between a combination of 200 mg ibuprofen and 30 mg pseudoephedrine film-coated tablets to the reference formulation RhinAdvil Rhume® 200 mg/30 mg (Wyeth Santé Familiale, France).
Condition or disease Intervention/treatment Phase

Fever

Pain, Acute

Pain, Back

Pain, Head

Drug: Ibuprofen/Pseudoephedrine HCl 200/30 mg Film-Coated Tablets
Other Names
Ibuprofen/Pseudoephedrine/test product
Drug: RhinAdvil Rhume 200 mg/30 mg Film-Coated Tablets
Other Names
RhinAdvil
Phase 1

Tracking Information

First Submitted DateJanuary 31, 2018
Last Update Posted DateFebruary 09, 2018
Actual Start DateApril 27, 2014
Actual Completion DateMay 05, 2014
Actual Primary Completion DateMay 05, 2014
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • AUC(0-t) (area under the analyte concentration versus time curve) of ibuprofen and pseudoephedrine, respectively [Time Frame: 7 days (± 3 hours)]

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

  • maximum serum concentration of ibuprofen and pseudoephedrine, respectively [Time Frame: 7 days (± 3 hours)]

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

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

Not Available

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleSingle-Dose Bioavailability Study of Two Formulations of Ibuprofen and Pseudoephedrine Hydrochloride Tablets
Official TitleA Single-Dose, Comparative Bioavailability Study of Two Formulations of Ibuprofen and Pseudoephedrine Hydrochloride 200 mg/30 mg Tablets Under Fasting Conditions
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.

Detailed Description

Ibuprofen is one of the most often used non steroidal antiinflammatory drug (NSAR) in the management of mild to moderate pain and inflammation. Combined with the sympathomimetic pseudoephedrine as decongestant it is widely used in colds or fever. The purpose of this phase-I-study was to evaluate the comparative bioavailability between a combination of 200 mg ibuprofen and 30 mg pseudoephedrine film-coated tablets to the reference formulation RhinAdvil Rhume® 200 mg/30 mg (Wyeth Santé Familiale, France).

Study TypeInterventional
Study PhasePhase 1
Estimated Enrollment
66
Allocation
Randomized
Interventional Model
Crossover Assignment
Masking
None (Open Label)
Primary Purpose
Treatment
Conditions
Fever
Pain, Acute
Pain, Back
Pain, Head
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
Intervention
Drug: Ibuprofen/Pseudoephedrine HCl 200/30 mg Film-Coated Tablets

Experimental drug

Other Names
Ibuprofen/Pseudoephedrine/test product
Drug: RhinAdvil Rhume 200 mg/30 mg Film-Coated Tablets

Active Comparator

Other Names
RhinAdvil
Study Groups/Cohorts
Experimental Drug
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

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

Study Arms
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
Active Comparator

Experimental Experimental Drug
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
Experimental drug

Arm Intervention/Treatment
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
Experimental Experimental Drug
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

Recruitment Information

Recruitment Status:Completed
Enrollment66
Completion DateMay 05, 2014
Eligibility Criteria: Inclusion Criteria:
1. Healthy, non-smoking, male and female subjects, 18 years of age or older.
2. BMI ≥ 18.5 and 30.0 kg/m2
3. No clinically significant findings in vital signs measurements.
4. No clinically significant abnormal laboratory values.
5. No clinically significant findings in a 12-lead electrocardiogram (ECG).
6. No significant diseases.
7. Willing to use an acceptable, effective method of contraception.
8. Be informed of the nature of the study and give written consent prior to any study procedure.
9. Have no clinically significant findings from a physical examination.

Exclusion Criteria:
1. Known history or presence of any clinically significant medical condition.
2. Known or suspected carcinoma.
3. History or presence of ulcerative colitis, diverticulosis, Crohn's disease, or gastrointestinal ulcer, perforation, or haemorrhage.
4. Known history or presence of auto-immune disorders, gastrointestinal toxicity, or a risk of gastrointestinal bleeding or gastrointestinal tract irritation.
5. 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.
6. Known history or presence of angioedema.
7. Known history or presence of galactose or fructose intolerance, sucraseisomaltase insufficiency, Lapp lactase insufficiency, galactosemia, or glucose-galactose malabsorption syndrome.
8. Known history of severe skin reactions (e.g. exfoliative dermatitis, SJS, and TEN).
9. Known history or presence of bronchial asthma or allergic disease resulting in bronchospasm.
10. Presence of hepatic or renal dysfunction.
11. Presence of clinically significant gastrointestinal disease or history of malabsorption within the last year.
12. Presence of a medical condition requiring regular medication (prescription and/or over-the-counter) with systemic absorption.
13. History of drug or alcohol addiction requiring treatment.
14. History of gastrointestinal bleeding or perforation when previously taking NSAIDs.
15. Positive test result for HIV, Hepatitis B surface antigen or Hepatitis C antibody.
16. Positive test result for urine drugs of abuse (cannabinoids, opiates, amphetamines, cocaine, phencyclidine, tricyclic antidepressants, barbiturates, methadone and benzodiazepines) or urine cotinine.
17. Difficulty fasting or consuming standard meals.
18. Does not tolerate venipuncture.
19. Use of tobacco or nicotine-containing products within 6 months prior to drug administration.
20. On a special diet within 30 days prior to drug administration (e.g., liquid, protein, raw food diet).
21. Participated in another clinical trial or received an investigational product within 30 days prior to drug administration.
22. Donation or loss of whole blood (including clinical trials):
- 50 mL and ≤ 499 mL within 30 days prior to drug administration
- 500 mL within 56 days prior to drug administration.
23. Females who:
Have discontinued or changed the use of implanted, intrauterine, intravaginal, or injected hormonal contraceptives within 6 months prior to dosing; Have discontinued or changed the use of oral or patch hormonal contraceptives within 1 month prior to drug administration; Are pregnant (serum hCG consistent with pregnancy); or Are lactating.
24. Have had a tattoo or body piercing within 30 days prior to drug administration.
25. Known history or presence of hypersensitivity or idiosyncratic reaction to ibuprofen, pseudoephedrine, NSAIDs, or any other drug substances with similar activity or any of the excipients in the drug products
26. Use of drugs in the phenethylamine and amphetamine chemical classes within 14 days prior to drug administration.
27. Use of NSAIDs (including cyclo-oxygenase-2 selective inhibitors) aspirin, corticosteroids, anticoagulants, selective serotonin-reuptake inhibitors, antihypertensives, diuretics, cardiac glycosides, lithium, methotrexate, cyclosporin, mifepristone, tacrolimus, zidovudine, linezolid, dopaminergic alkaloids, quinolone antibiotics, terpene derivatives, clobutinol, atropine, local anaesthetics, MAO inhibitors, vasoconstrictors, alpha sympathomimetic drugs, or anti-platelet agents within 30 days prior to drug administration.
28. Use of any drugs known to induce or inhibit hepatic drug metabolism within 30 days prior to drug administration. (e.g. barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole, antidepressants (SSRI), cimetidine, diltiazem, macrolides, imidazoles, neuroleptics, verapamil, fluoroquinolones, antihistamines).
GenderAll
Age18 Years to N/A
Accepts Healthy VolunteersAccepts Healthy Volunteers
Contacts
Not Available
Listed Location Countries
Canada

Administrative Information

NCT Number:NCT03429738
Other Study ID Numbers
PMRI study number 2014-3489
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible Party,
Study Sponsor
Institut für Pharmakologie und Präventive Medizin
Collaborators
Pharma Medica Research, Inc.
Investigators
Study Director
Latifa Yamlahi, MD
Pharma Medica Research, Inc.