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.

NCT01170637 | Completed Phase 1

• 2 other identifiers: 1024.72010-019052-45
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• AUC0-* (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) (*=infinity)

  1 month

Study Arms (4)

Ibuprofen 200 mg

ACTIVE COMPARATOR

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

Drug: Ibuprofen

Pseudoephedrine-HCl 30 mg

ACTIVE COMPARATOR

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

Drug: Pseudoephedrine-HCl

Ibuprofen 200 mg BI

ACTIVE COMPARATOR

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

Drug: Ibuprofen

Pseudoephedrine-HCl 30 mg BI

ACTIVE COMPARATOR

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

Drug: Pseudoephedrine-HCl

Interventions

Ibuprofen DRUG

200 mg oral administration (RhinAdvil(R))

Ibuprofen 200 mg

Pseudoephedrine-HCl DRUG

30 mg oral administration (BI product)

Pseudoephedrine-HCl 30 mg

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• Age 21 to 50 years
• BMI 18.5 to 29.9 kg/m2
• Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local legislation

You may not qualify if:

• Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance
• Any evidence of a clinically relevant concomitant disease
• Any relevant Gastrointestinal (e.g. ulcera, hernia, bleedings and spasm), hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• Any relevant surgery of the gastrointestinal tract (except appendectomy)
• Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
• History of relevant orthostatic hypotension, fainting spells or blackouts
• Chronic or relevant acute infections
• History of relevant allergy or hypersensitivity (including allergy to drug or its excipients) as judged clinically relevant by the investigator
• 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
• 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
• Participation in another trial with an investigational drug within 2 months prior to administration or during the trial
• Smoker (\>10 cigarettes or \>3 cigars or \>3 pipes/day)
• Inability to refrain from smoking on trial days as judged by the investigator
• Alcohol abuse (average consumption of more than 20 g/day in females and 30 g/day in males)
• Drug abuse

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

1024.7.1 Boehringer Ingelheim Investigational Site

Ingelheim, Germany

Location

MeSH Terms

Interventions

Ibuprofen; Acetaminophen

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Acetanilides; Anilides; Amides; Aniline Compounds; Amines

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 26, 2010
• First Posted: July 27, 2010
• Study Start: July 1, 2010
• Primary Completion: September 1, 2010
• Last Updated: August 31, 2018

Record last verified: 2018-08

Locations

DE (1)