Bioequivalence Study of Loratadine / Pseudoephedrine Sulfate 10/ 240 mg Extended-Release Tablets Under Fed Conditions

NCT00845546 | Completed DMC

• 1 other identifier: AA01112
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study was to compare the single-dose relative bioavailability of Ranbaxy and Schering (Claritin-D® 24 hour) 10 mg Loratadine/240 mg Pseudoephedrine Sulfate Extended-Release Tablets, in a fully replicated design, under fed conditions.

Conditions

Healthy

Keywords

Bioequivalence 10 mg Loratadine 240 mg Pseudoephedrine Sulfate Extended Release Tablets

Outcome Measures

Primary Outcomes (1)

• Relative bioavailability between Ranbaxy and Schering (Claritin-D® 24 hour) Loratadine 10mg /Pseudoephedrine Sulfate 240 mg Extended-Release Tablets under fed conditions

Study Arms (2)

1

EXPERIMENTAL

10 mg Loratadine/240 mg Pseudoephedrine Sulfate Extended-Release Tablets of Ranbaxy

Drug: 10 mg Loratadine/240 mg Pseudoephedrine Sulfate Extended-Release Tablets

2

ACTIVE COMPARATOR

(Claritin\_D® 24 hour) 10 mg Loratadine/240 mg Pseudoephedrine Sulfate Extended-Release Tablets

Drug: 10 mg Loratadine/240 mg Pseudoephedrine Sulfate Extended-Release Tablets

Interventions

10 mg Loratadine/240 mg Pseudoephedrine Sulfate Extended-Release Tablets DRUG

1; 2

Eligibility Criteria

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

You may qualify if:

• Healthy adult male or female volunteers, 18-45 years of agestart of the study.
• Other birth control methods may be deemed acceptable
• Postmenopausal women with amenorrhea for at least 2 years will be eligible
• Voluntarily consent to participate in the study

You may not qualify if:

• History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease
• In addition, history or presence of:
• alcoholism or drug abuse within the past year
• hypersensitivity or idiosyncratic reaction to Loratadine or any other H1-receptor antagonist
• hypersensitivity or idiosyncratic reaction to Pseudoephedrine or any other sympathomimetic amines
• Glaucoma or hypermetropia
• Subjects receiving a monoamine oxidase (MAO) inhibitor or within 14 days of stopping use of an MAO inhibitor, or any sympathomimetic amines
• Subjects who have used any drugs or other substances known to be strong inhibitors of CYP (cytochrome P450) enzymes within 10 days of study start
• Subjects who have used any drugs or other substances known to be strong inducers of CYP (cytochrome P450) enzymes within 28 days of study start
• Female subjects who are pregnant or lactating
• Subjects who have been on an abnormal diet (for whatever reason) during the 28 days prior to the first dose
• Subjects who, through completion of the study, would have donated in excess of:
• mL of blood in 14 days
• mL of blood in 14 days (unless approved by the principal Investigator)
• mL of blood in 90 days

Sponsors & Collaborators

• Ranbaxy Laboratories Limited: lead

Study Sites (1)

MDS Pharma Services

Saint-Laurent, Quebec, H4R 2N6, Canada

Location

Related Links

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Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 8, 2009
• First Posted: February 18, 2009
• Study Start: June 1, 2002
• Primary Completion: August 1, 2002
• Study Completion: November 1, 2002
• Last Updated: February 18, 2009

Record last verified: 2009-02

Locations

CA (1)