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

Ranbaxy

Status

Completed

Conditions

Healthy

Treatments

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

Study type

Interventional

Funder types

Industry

Identifiers

NCT00845546

AA01112

Details and patient eligibility

About

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.

Full description

The study was conducted as an open-label, randomized, Single-Dose, Fully replicated, 4-way Crossover Study 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 Healthy adult Volunteers Under Fed Conditions In each period, subjects were housed from the evenings before the dosing until after the 36 hour blood draw and were to return for subsequent blood draws at 48, 72, 96 and 120 hours post dose. Single oral 10 mg Loratadine/ 240 mg Pseudoephedrine Sulfate doses were separated by a washout period of 21 days.

A total of 40 subjects and 1 alternate (34 males and 7 females) were included in this study, of which 37 (32 males and 5 females) finished the study according to the protocol.

Enrollment

40 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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