Bioequivalence Study of Loratadine / Pseudoephedrine Sulfate 10/ 240 mg Extended-Release Tablets Under Fed Conditions
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00845546 |
Recruitment Status :
Completed
First Posted : February 18, 2009
Last Update Posted : February 18, 2009
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Healthy | Drug: 10 mg Loratadine/240 mg Pseudoephedrine Sulfate Extended-Release Tablets | Not Applicable |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 40 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (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 |
Study Start Date : | June 2002 |
Actual Primary Completion Date : | August 2002 |
Actual Study Completion Date : | November 2002 |

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

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00845546
Canada, Quebec | |
MDS Pharma Services | |
St. Laurent, Quebec, Canada, H4R 2N6 |
Responsible Party: | Dr. Tausif Monif, Ranbaxy Research labs |
ClinicalTrials.gov Identifier: | NCT00845546 |
Other Study ID Numbers: |
AA01112 |
First Posted: | February 18, 2009 Key Record Dates |
Last Update Posted: | February 18, 2009 |
Last Verified: | February 2009 |
Bioequivalence 10 mg Loratadine 240 mg Pseudoephedrine Sulfate Extended Release Tablets |
Malnutrition Nutrition Disorders Loratadine Pseudoephedrine Ephedrine Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Asthmatic Agents Respiratory System Agents Nasal Decongestants Vasoconstrictor Agents |
Central Nervous System Stimulants Sympathomimetics Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Antipruritics Dermatologic Agents Anti-Allergic Agents Histamine H1 Antagonists, Non-Sedating Histamine H1 Antagonists Histamine Antagonists Histamine Agents |