Trial Outcomes & Findings for Alendronate Sodium 70 mg Tablet Versus Fosamax® Under Fasting Conditions. (NCT NCT00835406)

NCT ID: NCT00835406

Last Updated: 2009-07-09

Results Overview

Rmax = maximum rate of urinary excretion

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 140 participants
• Primary outcome timeframe: Urine collected over 36 hour period
• Results posted on: 2009-07-09

Participant Flow

Participant milestones

Measure	Alendronate Sodium First 70 mg Alendronate Sodium Tablets test product dosed in first period followed by 70 mg Fosamax® Tablets reference product dosed in second period	Fosamax® First 70 mg Fosamax® Tablets reference product dosed in first period followed by 70 mg Alendronate Sodium Tablets test product dosed in second period.
Period: First Intervention STARTED	70	70
Period: First Intervention COMPLETED	68	69
Period: First Intervention NOT COMPLETED	2	1
Period: Washout of 7 Days STARTED	68	69
Period: Washout of 7 Days COMPLETED	68	67
Period: Washout of 7 Days NOT COMPLETED	0	2
Period: Second Intervention STARTED	68	67
Period: Second Intervention COMPLETED	68	67
Period: Second Intervention NOT COMPLETED	0	0

Reasons for withdrawal

Measure	Alendronate Sodium First 70 mg Alendronate Sodium Tablets test product dosed in first period followed by 70 mg Fosamax® Tablets reference product dosed in second period	Fosamax® First 70 mg Fosamax® Tablets reference product dosed in first period followed by 70 mg Alendronate Sodium Tablets test product dosed in second period.
Period: First Intervention Adverse Event	0	1
Period: First Intervention Withdrawal by Subject	2	0
Period: Washout of 7 Days Withdrawal by Subject	0	2

Baseline Characteristics

Alendronate Sodium 70 mg Tablet Versus Fosamax® Under Fasting Conditions.

Baseline characteristics by cohort

Measure	Alendronate Sodium First n=70 Participants 70 mg Alendronate Sodium Tablets test product dosed in first period followed by 70 mg Fosamax® Tablets reference product dosed in second period	Fosamax® First n=70 Participants 70 mg Fosamax® Tablets reference product dosed in first period followed by 70 mg Alendronate Sodium Tablets test product dosed in second period.	Total n=140 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	70 Participants n=5 Participants	70 Participants n=7 Participants	140 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	70 Participants n=5 Participants	70 Participants n=7 Participants	140 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	70 Participants n=5 Participants	69 Participants n=7 Participants	139 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Canada	70 participants n=5 Participants	70 participants n=7 Participants	140 participants n=5 Participants

PRIMARY outcome

Timeframe: Urine collected over 36 hour period

Rmax = maximum rate of urinary excretion

Outcome measures

Measure	Alendronate Sodium n=135 Participants 70 mg Alendronate Sodium Tablets test product dosed in either period	Fosamax® n=135 Participants 70 mg Fosamax® Tablets reference product dosed in either period
Bioequivalence Based on Rmax	73.96 ng/mL Standard Deviation 40.48	73.99 ng/mL Standard Deviation 39.00

PRIMARY outcome

Timeframe: Urine collected over 36 hour period

Ae0-36 = cumulative urine excretion

Outcome measures

Measure	Alendronate Sodium n=135 Participants 70 mg Alendronate Sodium Tablets test product dosed in either period	Fosamax® n=135 Participants 70 mg Fosamax® Tablets reference product dosed in either period
Bioequivalence Based on Ae0-36	219.28 ng/mL Standard Deviation 127.25	213.44 ng/mL Standard Deviation 118.05

Adverse Events

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Manager, Biopharmaceutics

TEVA Pharmaceuticals USA

Phone: 1-866-384-5525

Email: clinicaltrialqueries@tevausa.com

Results disclosure agreements

• Principal investigator is a sponsor employee Principal Investigator is not permitted to discuss or publish trial results.
• Publication restrictions are in place

Restriction type: OTHER