NCT01012934

Brief Summary

The objective of this study is to investigate the bioequivalence of Mylan's alendronate sodium 70 mg tablets to Merck's Fosamax 70 mg tablets following a single, oral 70 mg (1 x 70 mg) dose administration under fasting conditions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
110

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Jul 2002

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

July 1, 2002

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2002

Completed
7.1 years until next milestone

First Submitted

Initial submission to the registry

September 21, 2009

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 13, 2009

Completed
Last Updated

November 13, 2009

Status Verified

November 1, 2009

Enrollment Period

1 month

First QC Date

September 21, 2009

Last Update Submit

November 12, 2009

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • The 90% confidence interval for the LSMeans ratio of CPEAK, AUCL, and AUCI for the test and reference product should be between 80.00% and 125.00% for the natural log-transformed data.

    urine collection up to 36 hours

Study Arms (2)

1

EXPERIMENTAL

Alendronate Sodium Tablets, 70 mg

Drug: Alendronate Sodium Tablets, 70 mg

2

ACTIVE COMPARATOR

Fosamax Tablets, 70 mg

Drug: Fosamax Tablets, 70 mg

Interventions

Alendronate Sodium Tablets, 70 mgDRUG

1 x 70 mg, single-dose fasting

1
Fosamax Tablets, 70 mgDRUG

1 x 70 mg, single-dose fasting

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • healthy, adult subjects, 18 years and older
  • able to swallow medication

You may not qualify if:

  • institutionalized subjects
  • history of any significant disease
  • use of any prescription or OTC medications within 14 days of start of study
  • received any investigational products within 30 days prior to start of study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PRACS Insitute Ltd.

Fargo, North Dakota, 58104, United States

Location

Related Links

MeSH Terms

Interventions

Alendronate

Intervention Hierarchy (Ancestors)

DiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic Chemicals

Study Design

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

Study Record Dates

First Submitted

September 21, 2009

First Posted

November 13, 2009

Study Start

July 1, 2002

Primary Completion

August 1, 2002

Study Completion

August 1, 2002

Last Updated

November 13, 2009

Record last verified: 2009-11

Locations

US(1)