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

• Status: Completed
• Trial end date: 2002-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Ranbaxy Laboratories Limited
• Treatments: Ephedrine; Loratadine; Pseudoephedrine

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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:

• 500 mL of blood in 14 days

• 500-750 mL of blood in 14 days (unless approved by the principal Investigator)

• 1000 mL of blood in 90 days

• 1250 mL of blood in 120 days

• 1500 mL of blood in 180 days

• 2000 mL of blood in 270 days

• 2500 mL of blood in 1 days

• Subjects who have participated in another clinical trial within 28 days prior to the study start