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

Pain, Acute Clinical Trial

Official title:

A Single-Dose, Comparative Bioavailability Study of Two Formulations of Ibuprofen and Pseudoephedrine Hydrochloride 200 mg/30 mg Tablets Under Fasting Conditions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03429738
• Other study ID #: PMRI study number 2014-3489
• Status: Completed
• Phase: Phase 1
• First received: January 31, 2018
• Last updated: February 9, 2018
• Start date: April 27, 2014
• Est. completion date: May 5, 2014

Study information

• Verified date: February 2018
• Source: Institut für Pharmakologie und Präventive Medizin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: May 5, 2014
• Est. primary completion date: May 5, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Acute Pain
• Back Pain
• Fever
• Headache
• Pain, Acute
• Pain, Back
• Pain, Head

Intervention

Drug:
• Ibuprofen/Pseudoephedrine HCl 200/30 mg Film-Coated Tablets
Experimental drug
• RhinAdvil Rhume 200 mg/30 mg Film-Coated Tablets
Active Comparator

Locations

Country	Name	City	State
Canada	Pharma Medica Research Inc.	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Institut für Pharmakologie und Präventive Medizin	Pharma Medica Research, Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)