NCT01659931

Brief Summary

The objective of this study was to prove the bioequivalence of Montelukast Tablet under fasted conditions

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for early_phase_1 asthma

Timeline
Completed

Started Feb 2008

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

February 1, 2008

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

August 6, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 8, 2012

Completed
Last Updated

January 23, 2018

Status Verified

January 1, 2018

Enrollment Period

Same day

First QC Date

August 6, 2012

Last Update Submit

January 19, 2018

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

  • bioequivalence determined by statistical comparison Cmax

    9 days

Study Arms (2)

Montelukast

ACTIVE COMPARATOR

10 mg Tablet

Drug: Montelukast

Singulair

ACTIVE COMPARATOR

10 mg Tablet

Drug: Singulair

Interventions

MontelukastDRUG

10 mg Tablet

Also known as: Singulair
Montelukast
SingulairDRUG

10 mg Tablet

Also known as: Montelukast
Singulair

Eligibility Criteria

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

You may qualify if:

  • No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening

You may not qualify if:

  • Positive test for HIV, Hepatitis B, or Hepatitis C.
  • Treatment with known enzyme altering drugs.
  • History of allergic or adverse response to montelukast or any comparable or similar product.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PRACS Institute, Ltd.

Fargo, North Dakota, 58104, United States

Location

MeSH Terms

Conditions

Asthma

Interventions

montelukast

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Alan K Copa, PharmD

    PRACS Institute, Ltd.

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

August 6, 2012

First Posted

August 8, 2012

Study Start

February 1, 2008

Primary Completion

February 1, 2008

Study Completion

February 1, 2008

Last Updated

January 23, 2018

Record last verified: 2018-01

Locations

US(1)