NCT01133483

Brief Summary

The purpose of this study is to

  1. 1.Compare and evaluate the single dose, crossover, bioequivalence study of Fexofenadine HCl 180 mg + Pseudoephedrine HCl 240 mg ER Tablets and Allegra-D 24 hr tablets.
  2. 2.Monitor the adverse events and ensure the safety of subjects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Apr 2007

Shorter than P25 for phase_1 healthy

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

April 1, 2007

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2007

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

May 27, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 28, 2010

Completed
Last Updated

June 14, 2010

Status Verified

June 1, 2010

Enrollment Period

Same day

First QC Date

May 27, 2010

Last Update Submit

June 11, 2010

Conditions

Healthy

Keywords

BioequivalenceFexofenadine Hydrochloride + Pseudoephedrine Hydrochloride

Outcome Measures

Primary Outcomes (1)

  • Bioequivalence based on Cmax and AUC parameters

    2 months

Study Arms (2)

Fexofenadine HCl + Pseudoephedrine HCl

EXPERIMENTAL

Fexofenadine HCl 180 mg + Pseudoephedrine HCl 240 mg ER Tablets of Dr. Reddy's Laboratories

Drug: Fexofenadine HCl + Pseudoephedrine HCl

Allegra-D 24 hour ER Tablets

ACTIVE COMPARATOR

Allegra-D 24 hour ER Tablets of Aventis Pharmaceuticals INC., USA.

Drug: Fexofenadine HCl + Pseudoephedrine HCl

Interventions

Fexofenadine HCl + Pseudoephedrine HClDRUG

Fexofenadine HCl 180 mg + Pseudoephedrine HCl 240 mg ER Tablets of Dr. Reddy's Laboratories Limited

Also known as: Allegra-D 24 hour ER Tablets
Allegra-D 24 hour ER TabletsFexofenadine HCl + Pseudoephedrine HCl

Eligibility Criteria

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

You may qualify if:

  • Human subjects aged between 18 and 45 years (including both)
  • Subjects'weight within the normal range according to normal values for the Body Mass Index (18.5 to 24.9kgm2)with minimum of 50 kg weight.
  • Subjects with normal health as determined by personal medical history clinical examination and laboratory examinations within the clinically acceptable normal range.
  • Subjects having normal 12-lead electrocardiogram (ECG).
  • Subjects having normal chest X-Ray (P/A view).
  • Have a negative urine screen for drugs of abuse (including amphetamines,barbiturates, benzodiazepines, marijuana, cocaine, and morphine).
  • Have negative alcohol breath test.
  • Subjects willing to adhere to the protocol requirements and to provide written informed consent.

You may not qualify if:

  • Subjects will be excluded from the study, if they meet any of the following criteria:
  • Hypersensitivity to Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride or related drugs.
  • History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder.
  • History or presence of significant alcoholism or drug abuse in the past one year.
  • History or presence of significant smoking (more than 10 cigarettes or beedi's/day).
  • History or presence of significant asthma, urticaria or other allergic reactions.
  • History or presence of significant gastric and/or duodenal ulceration.
  • History or presence of significant thyroid disease, adrenal dysfunction, organic intracranial lesion such as pituitary tumour.
  • History or presence of cancer.
  • Difficulty with donating blood.
  • Difficulty in swallowing solids like tablets or capsules.
  • Systolic blood pressure less than 100 mm Hg or more than 140 mm Hg.
  • Diastolic blood pressure less than SO mm Hg or more than 90 mm Hg.
  • Pulse rate less than 50/minute or more than 100/minute.
  • Oral temperature less than 95°F or more than 98.5°F.
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Veeda Clinical Research Pvt. Ltd.,

Ahmedabad, Gujarat, 380015, India

Location

MeSH Terms

Interventions

fexofenadinePseudoephedrine

Intervention Hierarchy (Ancestors)

PropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesPhenethylaminesEthylamines

Study Officials

  • Dr. Dharmesh Domadia

    Veeda Clinical Research Pvt. Ltd.,

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

May 27, 2010

First Posted

May 28, 2010

Study Start

April 1, 2007

Primary Completion

April 1, 2007

Study Completion

May 1, 2007

Last Updated

June 14, 2010

Record last verified: 2010-06

Locations

IN(1)