Trial Outcomes & Findings for Desmopressin Acetate 0.2 mg Tablets, Fasting (NCT NCT00835211)

NCT ID: NCT00835211

Last Updated: 2009-09-11

Results Overview

Bioequivalence based on Cmax

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 48 participants
• Primary outcome timeframe: Blood samples collected over 12 hour period
• Results posted on: 2009-09-11

Participant Flow

Participant milestones

Measure	Desmopressin Acetate Desmopressin Acetate 4 x 0.2 mg Tablet (test) dosed in first period followed by DDAVP® 4 x 0.2 mg Tablet (reference) dosed in second period	DDAVP® DDAVP® 4 x 0.2 mg Tablet (reference) dosed in first period followed by Desmopressin Acetate 4 x 0.2 mg Tablet (test) dosed in second period
First Intervention STARTED	24	24
First Intervention COMPLETED	24	23
First Intervention NOT COMPLETED	0	1
Washout: 7 Days STARTED	24	23
Washout: 7 Days COMPLETED	21	22
Washout: 7 Days NOT COMPLETED	3	1
Second Intervention STARTED	21	22
Second Intervention COMPLETED	21	22
Second Intervention NOT COMPLETED	0	0

Reasons for withdrawal

Measure	Desmopressin Acetate Desmopressin Acetate 4 x 0.2 mg Tablet (test) dosed in first period followed by DDAVP® 4 x 0.2 mg Tablet (reference) dosed in second period	DDAVP® DDAVP® 4 x 0.2 mg Tablet (reference) dosed in first period followed by Desmopressin Acetate 4 x 0.2 mg Tablet (test) dosed in second period
First Intervention Withdrawal by Subject	0	1
Washout: 7 Days Adverse Event	2	1
Washout: 7 Days Withdrawal by Subject	1	0

Baseline Characteristics

Desmopressin Acetate 0.2 mg Tablets, Fasting

Baseline characteristics by cohort

Measure	Desmopressin Acetate n=24 Participants Desmopressin Acetate 4 x 0.2 mg Tablet (test) dosed in first period followed by DDAVP® 4 x 0.2 mg Tablet (reference) dosed in second period	DDAVP® n=24 Participants DDAVP® 4 x 0.2 mg Tablet (reference) dosed in first period followed by Desmopressin Acetate 4 x 0.2 mg Tablet (test) dosed in second period	Total n=48 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	24 Participants n=5 Participants	24 Participants n=7 Participants	48 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	12 Participants n=5 Participants	6 Participants n=7 Participants	18 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	18 Participants n=7 Participants	30 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	22 Participants n=5 Participants	20 Participants n=7 Participants	42 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized Black	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment Canada	24 participants n=5 Participants	24 participants n=7 Participants	48 participants n=5 Participants

PRIMARY outcome

Timeframe: Blood samples collected over 12 hour period

Population: Data from all subjects who completed the study were included in the statistical analysis.

Bioequivalence based on Cmax

Outcome measures

Measure	Desmopressin Acetate n=43 Participants Desmopressin Acetate 4 x 0.2 mg Tablet (test) dosed in either period	DDAVP® n=43 Participants DDAVP® 4 x 0.2 mg Tablet (reference) dosed in either period
Cmax - Maximum Observed Concentration	78.102 pg/mL Standard Deviation 52.5437	82.888 pg/mL Standard Deviation 64.2238

PRIMARY outcome

Timeframe: Blood samples collected over 12 hour period

Population: AUC0-inf could not be estimated for one subject in the reference arm.

Bioequivalence based on AUCinf

Outcome measures

Measure	Desmopressin Acetate n=43 Participants Desmopressin Acetate 4 x 0.2 mg Tablet (test) dosed in either period	DDAVP® n=42 Participants DDAVP® 4 x 0.2 mg Tablet (reference) dosed in either period
AUCinf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)	266.62 pg*h/mL Standard Deviation 169.435	286.34 pg*h/mL Standard Deviation 199.268

PRIMARY outcome

Timeframe: Blood samples collected over 12 hour period

Population: Data from all subjects who completed the study were included in the statistical analysis.

Bioequivalence based on AUC0-t

Outcome measures

Measure	Desmopressin Acetate n=43 Participants Desmopressin Acetate 4 x 0.2 mg Tablet (test) dosed in either period	DDAVP® n=43 Participants DDAVP® 4 x 0.2 mg Tablet (reference) dosed in either period
AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)	252.85 pg*h/mL Standard Deviation 162.914	268.02 pg*h/mL Standard Deviation 188.907

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