Bioequivalence Study of Loratadine / Pseudoephedrine Sulfate 10/ 240 mg Extended-Release Tablets Under Fed Conditions
This study has been completed.
Sponsor:
Ranbaxy Laboratories Limited
Information provided by:
Ranbaxy Inc.
ClinicalTrials.gov Identifier:
NCT00845546
First received: January 8, 2009
Last updated: February 16, 2009
Last verified: February 2009
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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:
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 |
| 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 More Information
Additional Information:
No publications provided
| 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:
|
Pseudoephedrine Ephedrine Loratadine Nasal Decongestants Vasoconstrictor Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Respiratory System Agents Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Asthmatic Agents |
Central Nervous System Stimulants Central Nervous System Agents 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 |
ClinicalTrials.gov processed this record on June 17, 2013