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.

Bioequivalence of a Fixed Dose Combination Tablet Containing 200 mg Ibuprofen and 30 mg Pseudoephedrine-HCl Compared to RhinAdvil® (200 mg Ibuprofen and 30 mg Pseudoephedrine-HCl) as a Fixed Dose Combination Tablet Administered in Healthy Male and Female Volunteers (Open-label, Randomised, Single Dose, Two-way Crossover, Phase I Trial).

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Ibuprofen; Drug: Ibuprofen; Drug: Pseudoephedrine-HCl; Drug: Pseudoephedrine-HCl

• Study Type: Interventional
• Enrollment (Actual): 47
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Ingelheim, Germany
    • 1024.7.1 Boehringer Ingelheim Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Ibuprofen 200 mg; Oral administration as a fixed dose combination tablet (RhinAdvil(R))	Drug: Ibuprofen; 200 mg oral administration (RhinAdvil(R)); Drug: Ibuprofen; 200 mg oral administration (BI product)
Active Comparator: Pseudoephedrine-HCl 30 mg; Oral administration as a fixed dose combination tablet (RhinAdvil(R))	Drug: Pseudoephedrine-HCl; 30 mg oral administration (BI product); Drug: Pseudoephedrine-HCl; 30 mg oral administration (RhinAdvil(R))
Active Comparator: Ibuprofen 200 mg BI; Oral administration as a fixed dose combination tablet (BI product)	Drug: Ibuprofen; 200 mg oral administration (RhinAdvil(R)); Drug: Ibuprofen; 200 mg oral administration (BI product)
Active Comparator: Pseudoephedrine-HCl 30 mg BI; Oral administration as a fixed dose combination tablet (BI product)	Drug: Pseudoephedrine-HCl; 30 mg oral administration (BI product); Drug: Pseudoephedrine-HCl; 30 mg oral administration (RhinAdvil(R))

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of last quantifiable time point)	1 month
Cmax (maximum measured concentration of the analyte in plasma)	1 month

Secondary Outcome Measures

Outcome Measure	Time Frame
AUC0-* (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) (*=infinity)	1 month

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Actual): September 1, 2010

Study Registration Dates

• First Submitted: July 26, 2010
• First Submitted That Met QC Criteria: July 26, 2010
• First Posted (Estimate): July 27, 2010

Study Record Updates

• Last Update Posted (Actual): August 31, 2018
• Last Update Submitted That Met QC Criteria: August 29, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Central Nervous System Stimulants; Sympathomimetics; Vasoconstrictor Agents; Nasal Decongestants; Ibuprofen; Ephedrine; Pseudoephedrine
• Other Study ID Numbers: 1024.7; 2010-019052-45 (EudraCT Number: EudraCT)