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

Purpose

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.

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


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Crossover Assignment Masking: Open Label
Official Title:	Comparative, Randomized, Single-Dose, Fully Replicated, 4-Way Crossover Bioavailability Study 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

Resource links provided by NLM:

MedlinePlus related topics: Malnutrition

Drug Information available for: Ephedrine Hydrochloride Pseudoephedrine Ephedrine sulfate Pseudoephedrine hydrochloride Sulfate ion Loratadine

U.S. FDA Resources

Further study details as provided by Ranbaxy Inc.:

Primary Outcome Measures:

Relative bioavailability between Ranbaxy and Schering (Claritin-D® 24 hour) Loratadine 10mg /Pseudoephedrine Sulfate 240 mg Extended-Release Tablets under fed conditions [ Designated as safety issue: No ]


Enrollment:	40
Study Start Date:	June 2002
Study Completion Date:	November 2002
Primary Completion Date:	August 2002 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 10 mg Loratadine/240 mg Pseudoephedrine Sulfate Extended-Release Tablets of Ranbaxy	Drug: 10 mg Loratadine/240 mg Pseudoephedrine Sulfate Extended-Release Tablets
Active Comparator: 2 (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

Detailed 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.

Eligibility


Ages Eligible for Study:	18 Years to 45 Years (Adult)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00845546

Locations


Canada, Quebec
MDS Pharma Services
St. Laurent, Quebec, Canada, H4R 2N6

Sponsors and Collaborators

Ranbaxy Laboratories Limited

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site


Responsible Party:	Dr. Tausif Monif, Ranbaxy Research labs
ClinicalTrials.gov Identifier:	NCT00845546 History of Changes
Other Study ID Numbers:	AA01112
Study First Received:	January 8, 2009
Last Updated:	February 16, 2009
Health Authority:	Canada: Health Canada

Keywords provided by Ranbaxy Inc.:


Bioequivalence 10 mg Loratadine 240 mg Pseudoephedrine Sulfate Extended Release Tablets

Additional relevant MeSH terms:


Loratadine Ephedrine Pseudoephedrine Antipruritics Dermatologic Agents Anti-Allergic Agents Histamine H1 Antagonists, Non-Sedating Histamine H1 Antagonists Histamine Antagonists Histamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action	Physiological Effects of Drugs Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Anti-Asthmatic Agents Respiratory System Agents Nasal Decongestants Vasoconstrictor Agents Central Nervous System Stimulants Sympathomimetics Adrenergic Agents

ClinicalTrials.gov processed this record on September 23, 2016