NCT01012934

CompletedPhase 1

Fasting Study of Alendronate Sodium Tablets (70 mg) and Fosa...

Mylan Pharmaceuticals Inc Source

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Other study identifiers

Sponsor study identifier

ALEN-0244

Study Type

interventional

Actual enrollment (reported)

110

Locations

1 country

Sites

1

Timeline

Study Start

July 2002

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

August 2002

Actual (reported)

Study Completion

August 2002

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 110 participants
Study completion date: August 2002
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
July 2002
Date type not reported
This date has not been verified as actual or estimated.
Primary Completion
August 2002
Actual (reported)
Study Completion
August 2002
Actual (reported)
First Submitted
September 21, 2009
Actual (reported)
First Posted
November 13, 2009
Actual (reported)

Last Updated: November 13, 2009
Status Verified: November 2009
Last Update Submitted: 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:

Sponsors & Collaborators

Mylan Pharmaceuticals Inc
Industrylead

Study Sites (1)

PRACS Insitute Ltd.

Fargo, North Dakota, 58104, United States

MeSH Terms

Interventions

Alendronate

Intervention Hierarchy (Ancestors)

DiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic Chemicals

Enrollment

110 participants (actual enrollment reported by the registry).

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 2002

Date type not reported

This date has not been verified as actual or estimated.

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NCT00649597

Fasting Study of Benazepril HCl and Hydrochlorothiazide Tablets 20 mg/25 mg to Lotensin HCT® Tablets 20 mg/25 mg

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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.

Primary Completion

August 2002

Actual (reported)

Study Completion

August 2002

Actual (reported)

Last Updated

November 13, 2009

Record last verified: 2009-11

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT01012934
Data provider: ClinicalTrials.gov
Source updated: 2009-11-13
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:36:48 UTC

Locations

US(1)

Fasting Study of Alendronate Sodium Tablets (70 mg) and Fosamax Tablets (70 mg)

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

1

2

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Links

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

1

2

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Links

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

Source record

Locations