Bioequivalence of a Fixed Dose Combination Tablet Containing 200 mg Ibuprofen and 30 mg Pseudoephedrine-HCl Compared to RhinAdvil(R)(200 mg Ibuprofen and 30 mg Pseudoephedrine-HCl) as a Fixed Dose Combination Tablet Administered in Healthy Volunteers.

NCT ID: NCT01170637

Last Updated: 2018-08-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-31

Brief Summary

The objective of the current study is to demonstrate bioequivalence of a fixed dose combination tablet containing ibuprofen 200 mg and pseudoephedrine-HCl 30 mg (Test) and RhinAdvil® (Reference) a fixed dose combination tablet containing ibuprofen 200 mg and pseudoephedrine-HCl 30 mg following orally administration.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ibuprofen 200 mg

Oral administration as a fixed dose combination tablet (RhinAdvil(R))

Group Type: ACTIVE_COMPARATOR

Ibuprofen

Intervention Type: DRUG

200 mg oral administration (RhinAdvil(R))

Pseudoephedrine-HCl 30 mg

Oral administration as a fixed dose combination tablet (RhinAdvil(R))

Group Type: ACTIVE_COMPARATOR

Pseudoephedrine-HCl

Intervention Type: DRUG

30 mg oral administration (BI product)

Ibuprofen 200 mg BI

Oral administration as a fixed dose combination tablet (BI product)

Group Type: ACTIVE_COMPARATOR

Ibuprofen

Intervention Type: DRUG

200 mg oral administration (BI product)

Pseudoephedrine-HCl 30 mg BI

Oral administration as a fixed dose combination tablet (BI product)

Group Type: ACTIVE_COMPARATOR

Pseudoephedrine-HCl

Intervention Type: DRUG

30 mg oral administration (RhinAdvil(R))

Interventions

Ibuprofen

200 mg oral administration (RhinAdvil(R))

Intervention Type: DRUG

Ibuprofen

200 mg oral administration (BI product)

Intervention Type: DRUG

Pseudoephedrine-HCl

30 mg oral administration (BI product)

Intervention Type: DRUG

Pseudoephedrine-HCl

30 mg oral administration (RhinAdvil(R))

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Healthy males and females according to the following criteria:

Based upon a complete medical history, including physical examination, vital signs (Blood pressure (BP), Pulse rate (PR)), 12-lead electrocardiogram (ECG), clinical laboratory tests

2. Age 21 to 50 years

3. BMI 18.5 to 29.9 kg/m2

4. Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local legislation

Exclusion Criteria

1. Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance

2. Any evidence of a clinically relevant concomitant disease

3. Any relevant Gastrointestinal (e.g. ulcera, hernia, bleedings and spasm), hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders

4. Any relevant surgery of the gastrointestinal tract (except appendectomy)

5. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders

6. History of relevant orthostatic hypotension, fainting spells or blackouts

7. Chronic or relevant acute infections

8. History of relevant allergy or hypersensitivity (including allergy to drug or its excipients) as judged clinically relevant by the investigator

9. Intake of drugs with a long half-life (>24 hours) within at least 1 month or less than 10 half-lives of the respective drug prior to first drug administration

10. Use of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 10 days prior to randomisation

11. Participation in another trial with an investigational drug within 2 months prior to administration or during the trial

12. Smoker (>10 cigarettes or >3 cigars or >3 pipes/day)

13. Inability to refrain from smoking on trial days as judged by the investigator

14. Alcohol abuse (average consumption of more than 20 g/day in females and 30 g/day in males)

15. Drug abuse

16. Blood donation (more than 100 mL within four weeks prior to administration of the trial drug in this study)

17. Excessive physical activities within 1 week prior to randomisation or during the trial

18. Any laboratory value outside the reference range that is of clinical relevance

19. Inability to comply with dietary regimen of the study centre

20. Unwilling to avoid excessive sunlight exposure

21. Use of drugs which might reasonably influence the results of the trial or that prolong the QT/QTc interval within 10 days prior to administration or during the trial, and CYP2C8 substrates such as amiodarone, amodiaquine, paclitaxel, rosiglitazone, pioglitazone and repaglinide or CYP2C9 such as warfarin, tolbutamide, phenytoin, losartan, acenocoumarol within 1 month or six half lives (whichever is greater)

22. A marked baseline prolongation of the QTc interval (e.g., repeated demonstration of a QTc interval >450 ms)

23. A history of additional risk factors for torsade de pointes (e.g., heart failure, hypokalaemia, family history of Long QT Syndrome)

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Boehringer Ingelheim

Principal Investigators

Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

1024.7.1 Boehringer Ingelheim Investigational Site

Ingelheim, , Germany

Countries

Germany

Other Identifiers

2010-019052-45

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1024.7

Identifier Type: -

Identifier Source: org_study_id