NCT00983996

Brief Summary

The objective of this study is to investigate the bioequivalence of Mylan's alendronate sodium 10 mg tablets to Merck's Fosamax 10 mg tablets following a single, oral 40 mg (4 x 10 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
112

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Jun 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

June 1, 2002

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2002

Completed
7.2 years until next milestone

First Submitted

Initial submission to the registry

September 21, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 24, 2009

Completed
Last Updated

September 24, 2009

Status Verified

September 1, 2009

Enrollment Period

1 month

First QC Date

September 21, 2009

Last Update Submit

September 22, 2009

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Bioequivalence

    urine collection up to 36 hours

Study Arms (2)

1

EXPERIMENTAL

Alendronate Sodium Tablets, 10 mg

Drug: Alendronate Sodium Tablets, 10 mg

2

ACTIVE COMPARATOR

Fosamax Tablets, 10 mg

Drug: Fosamax Tablets, 10 mg

Interventions

Alendronate Sodium Tablets, 10 mgDRUG

10 mg, single-dose fasting

1
Fosamax Tablets, 10 mgDRUG

10 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

September 24, 2009

Study Start

June 1, 2002

Primary Completion

July 1, 2002

Study Completion

July 1, 2002

Last Updated

September 24, 2009

Record last verified: 2009-09

Locations

US(1)