NCT00837915

Brief Summary

The objective of this study was to compare the single-dose relative bioavailability of Ranbaxy and Schering (Claritin-D® 24 hour) Loratadine 10mg /Pseudoephedrine Sulfate 240 mg Extended-Release Tablets, in a fully replicated design, under fasting conditions.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Jun 2002

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2002

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2002

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2002

Completed
6.2 years until next milestone

First Submitted

Initial submission to the registry

January 8, 2009

Completed
29 days until next milestone

First Posted

Study publicly available on registry

February 6, 2009

Completed
Last Updated

February 6, 2009

Status Verified

February 1, 2009

Enrollment Period

2 months

First QC Date

January 8, 2009

Last Update Submit

February 5, 2009

Conditions

Healthy

Keywords

Bioequivaelnce Loratadine 10mg /Pseudoephedrine Sulfate 240 mg Extended Release Tablets

Outcome Measures

Primary Outcomes (1)

  • Relative bioavailability between Ranbaxy and Schering (Claritin-D® 24 hour) Loratadine 10mg /Pseudoephedrine Sulfate 240 mg Extended-Release Tablets under fasting conditions

Study Arms (2)

1

EXPERIMENTAL

Loratadine 10mg /Pseudoephedrine Sulfate 240 mg Extended-Release Tablets of Ranbaxy

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

2

ACTIVE COMPARATOR

(Claritin-D® 24 hour) Loratadine 10mg /Pseudoephedrine Sulfate 240 mg Extended-Release Tablets

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

Interventions

Loratadine 10mg /Pseudoephedrine Sulfate 240 mg Extended-Release TabletsDRUG
12

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy adult male or female volunteers, 18-45 years of age
  • Weighing at least 60 kg for males and 52 kg for females and within 15% of their ideal weights (Table of "Desirable Weights of Adults", Metropolitan Life Insurance Company, 1983);
  • Medically healthy subjects with clinically normal laboratory profiles;
  • Females of childbearing potential should either be sexually inactive (abstinent) for 14 days prior to the study and throughout the study or be using one of the following acceptable birth control methods:
  • surgically sterile (bilateral tubal ligation, hysterectomy bilateral oophorectomy) 6 months minimum
  • IUD in place for at least 3 months
  • barrier methods (condom, diaphragm) with spermicide for at least 14 days prior to the start of the study and .throughout the study
  • surgical sterilization of the partner (vasectomy for 6 months minimum
  • hormonal contraceptives for at least 3 months prior to the start 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.

You may not qualify if:

  • Subject candidates must not be enrolled in the study if they meet any of the following 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 loratidine or any other H1-receptor antagonist
  • hypersensitivity or idiosyncratic reaction to pseudoephederine or any other sympatomimetic 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 completition of the study, would have donated in excess of:
  • mL of blood in 14 days, or
  • mL of blood in 14 days (unless approved by the principal Investigator),
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MDS Pharma Services

Montreal, Quebec, H4R2N6, Canada

Location

Related Links

MeSH Terms

Interventions

LoratadineAcetaminophen

Intervention Hierarchy (Ancestors)

CyproheptadineDibenzocycloheptenesBenzocycloheptenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPolycyclic CompoundsAcetanilidesAnilidesAmidesAniline CompoundsAmines

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 8, 2009

First Posted

February 6, 2009

Study Start

June 1, 2002

Primary Completion

August 1, 2002

Study Completion

November 1, 2002

Last Updated

February 6, 2009

Record last verified: 2009-02

Locations

CA(1)