NCT00946608

Brief Summary

To demonstrate the relative bioavailability study of Loratadine 10 mg tablets.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jun 2005

Shorter than P25 for phase_1

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, 2005

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2005

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

July 24, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 27, 2009

Completed
Last Updated

March 28, 2017

Status Verified

July 1, 2009

Enrollment Period

2 months

First QC Date

July 24, 2009

Last Update Submit

March 27, 2017

Conditions

Allergy

Keywords

Antihistamine

Outcome Measures

Primary Outcomes (1)

  • Bioequivalence based on AUC and Cmax

    54 days

Study Arms (3)

1

EXPERIMENTAL

Loratadine 10 mg Tablets Under Fasting Conditions (Sandoz, Inc.)

Drug: Loratadine 10 mg Tablets Under Fasting Conditions (Sandoz, Inc.)

2

EXPERIMENTAL

Loratadine 10 mg Tablets Under Fed Conditions (Sandoz, Inc.)

Drug: Loratadine 10 mg Tablets Under Fed Conditions (Sandoz, Inc.)

3

ACTIVE COMPARATOR

Claritin (Loratadine) 10 mg Tablets Under Fed Conditions (Schering)

Drug: Claritin (Loratadine) 10 mg Tablets Under Fed Conditions (Schering)

Interventions

Loratadine 10 mg Tablets Under Fasting Conditions (Sandoz, Inc.)DRUG
1
Loratadine 10 mg Tablets Under Fed Conditions (Sandoz, Inc.)DRUG
2
Claritin (Loratadine) 10 mg Tablets Under Fed Conditions (Schering)DRUG
3

Eligibility Criteria

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

You may qualify if:

  • No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

You may not qualify if:

  • Positive test results for HIV or hepatitis B or C.
  • Treatment for drug or alcohol dependence.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hypersensitivity

Interventions

Loratadine

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Gaetano Morelli, M.D.

    Early Clinical Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 24, 2009

First Posted

July 27, 2009

Study Start

June 1, 2005

Primary Completion

August 1, 2005

Study Completion

August 1, 2005

Last Updated

March 28, 2017

Record last verified: 2009-07