Bioequivalence Study of Desloratadine and Pseudoephedrine Sulfate Extended-release Tablets Under Fasting Conditions

NCT01373138 | Completed Phase 1

• 1 other identifier: 50630
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open label randomised, 2-way crossover, comparative bioequivalence study.

Conditions

Healthy

Keywords

Bioequivalence; Desloratadine and pseudoephedrine; crossover

Outcome Measures

Primary Outcomes (1)

• Bioequivalence based on Cmax and AUC parameters

  3 months

Study Arms (2)

Desloratadine and pseudoephedrine ER tablets 5/240 mg

EXPERIMENTAL

Desloratadine and pseudoephedrine ER tablets 5/240 mg of Dr. Reddy's Laboratories Limited

Drug: Desloratadine and pseudoephedrine

Clarinex D 24-hour

ACTIVE COMPARATOR

Clarinex D-24 of Schering Corporation Inc USA

Drug: Desloratadine and pseudoephedrine

Interventions

Desloratadine and pseudoephedrine DRUG

Desloratadine and pseudoephedrine 5/240 mg

Also known as: Clarinex D-24

Clarinex D 24-hour; Desloratadine and pseudoephedrine ER tablets 5/240 mg

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female, non-smoker, ≥18 and ≤45 years of age.
• Capable of consent.
• Medically healthy with clinically normal laboratory profile, vital signs and ECG.
• BMI ≥19.0 and ≤30.0.

You may not qualify if:

• Clinically significant illness or surgery within 4 weeks prior to dosing.
• Any clinically significant abnormality or abnormal laboratory test results found during medical screening.
• Any reason which, in the opinion of the Medical Sub-Investigator, would prevent the subject from participating in the study.
• Positive test for hepatitis B, hepatitis C, or HIV at screening.
• ECG abnormalities (clinically significant) or vital sign abnormalities (systolic blood pressure lower than 90 or over 140 mmHg, diastolic blood pressure lower than 50 or over 90 mmHg, or heart rate less than 50 or over 100 bpm) at screening.
• History of significant alcohol abuse or drug abuse within one year prior to the screening visit.
• Regular use of alcohol within six months prior to the screening visit (more than fourteen units of alcohol per week \[1 Unit = 150 mL of wine, 360 mL of beer, or 45 mL of 40% alcohol\]).
• Use of soft drugs (such as marijuana) within 3 months prior to the screening visit or hard drugs (such as cocaine, phencyclidine \[PCP\] and crack) within 1 year prior to the screening visit or positive urine drug screen at screening.
• History of allergic reactions to desloratadine, pseudoephedrine or other related drugs.
• Use of any drugs known to induce or inhibit hepatic drug metabolism (examples of inducers: barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; examples of inhibitors: antidepressants (SSRI), cimetidine, diltiazem, macrolides, imidazoles, neuroleptics, verapamil, fluoroquinolones, antihistamines) within 30 days prior to administration of the study medication.
• Use of an investigational drug or participation in an investigational study within 30 days prior to dosing.
• Clinically significant history or presence of any gastrointestinal pathology (e.g. chronic diarrhea, inflammatory bowel diseases), unresolved gastrointestinal symptoms (e.g.diarrhea, vomiting), liver or kidney disease, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of the drug.
• Any clinically significant history or presence of neurological, endocrinal, cardiovascular, pulmonary, hematologic, immunologic, psychiatric, or metabolic disease.
• Use of prescription medication within 14 days prior to administration of study medication or over-the-counter products (including natural food supplements, vitamins, garlic as a supplement) within 7 days prior to administration of study medication, except for topical products without systemic absorption and hormonal contraceptives.
• Difficulty to swallow study medication.

Sponsors & Collaborators

• Dr. Reddy's Laboratories Limited: lead

Study Sites (1)

SFBC Anapharm

Sainte-Foy (Quebec), G1V 2K8, Canada

Location

MeSH Terms

Interventions

desloratadine; Pseudoephedrine

Intervention Hierarchy (Ancestors)

Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Phenethylamines; Ethylamines

Study Officials

• Dr.Denis Audet, MD

  SFBC Anapharm

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 10, 2011
• First Posted: June 14, 2011
• Study Start: April 1, 2006
• Study Completion: May 1, 2006
• Last Updated: June 14, 2011

Record last verified: 2006-06

Locations

CA (1)