HealthyPhase 1NCT00835211

Desmopressin Acetate 0.2 mg Tablets, Fasting

A Phase 1 study testing Desmopressin Acetate 0.2 mg Tablets and DDAVP® 0.2 mg Tablets in people with Healthy, run by Teva Pharmaceuticals USA at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The objective of this study was to compare the single-dose relative bioavailability of TEVA and Aventis Pharmaceuticals (DDAVP®) 0.2 mg desmopressin acetate tablets following a 0.8 mg dose under fasting conditions. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Desmopressin Acetate 0.2 mg Tablets and DDAVP® 0.2 mg Tablets
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 48 participants
Where: 1 siteCanada
Study dates: Jul 2003to Aug 2003
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy adult non-smoker (for at least 3 months) or light smoking (less than 10 cigarettes per day for at least 3 months) male or female subjects, 18-55 years of age;
Weighing at least 60 kg for males and 52 kg for females;
Subjects who had a body mass index (BMI) less than 30;
Medically healthy subjects with clinically normal laboratory profiles and ECGs;
Females of childbearing potential should have either been sexually inactive (abstinent) for 14 days prior to the first dose and throughout the study or have been using one of the following acceptable birth control methods:
surgically sterile (tubal ligation, hysterectomy, bilateral oophorectomy) 6 months minimum. Proof was required for the hysterectomy and oophorectomy;

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IUD in place for at least 3 months;
barrier methods (condom, diaphragm) with spermicide for at least 14 days prior to the first dose and throughout the study;
surgical sterilization of the partner (vasectomy for 6 months minimum);
hormonal contraceptives for at least 3 months prior to the first dose of the study.
Other birth control methods were deemed acceptable. Postmenopausal women with amenorrhea for at least 2 years were eligible.
Voluntarily consent to participate in the study.

Who cannot join

Female subjects who were pregnant or lactating.
Subjects who had been on a special diet (for whatever reason) during the 28 days prior to the first dose and throughout the study.
Any clinically significant illness within 4 weeks prior to dosing.
Subjects with any medical condition requiring regular treatment with prescription drugs.
The use of any pharmacological agents known to significantly induce or inhibit drug-metabolizing enzymes within 30 days prior to the first dose.
Subjects who, through completion of the study, would have donated in excess of: 500 mL of blood and/or plasma in 14 days; 1500 mL of blood and/or plasma in 180 days; 2500 mL of blood and/or plasma in 1 year.

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Subjects who had donated plasma within 30 days prior to the first dose.
Subjects who ahd participated in another clinical trial within 30 days prior to the first dose.
Subjects who did not tolerate venipuncture.
History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease.
In addition, the history or presence of:
hypersensitivity or idiosyncratic reaction to desmopressin or any other synthetic anti-diuretic hormones;
type IIB von Willebrand's disease;
personal or family bleeding disorder;
alcoholism or drug abuse within the past year.

Trial locations and contacts

1 site in 1 country.

Canada1 site

MDS Pharma Sercives
Saint-Laurent, Quebec, H4R 2N6

Other trials in Canada

About this study

Official title: Comparative, Randomized, Single-Dose, 2-way Crossover Bioavailability Study of TEVA and Aventis Pharmaceuticals (DDAVP®) 0.2 mg Desmopressin Acetate Tablets in Healthy Adult Subjects Following a 0.8 mg Dose Under Fasting Conditions

Read the detailed description

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

Conditions: Healthy
Being tested: Desmopressin Acetate 0.2 mg Tablets, DDAVP® 0.2 mg Tablets
Keywords: Bioequivalence, Healthy Subjects

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Desmopressin Acetate 0.2 mg TabletsDrug
4 x 0.2 mg, single-dose fasting
DDAVP® 0.2 mg TabletsDrug
4 x 0.2 mg, single-dose fasting

Study groups in NCT00835211
Study group	Role	What they receive
1	Experimental	Not described Receives: Drug: Desmopressin Acetate 0.2 mg Tablets
2	Active comparator	Not described Receives: Drug: DDAVP® 0.2 mg Tablets

What is being measured

The primary outcome is the main question the study is designed to answer.

Cmax - Maximum Observed Concentration
Bioequivalence based on Cmax
Measured: Blood samples collected over 12 hour period
AUCinf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)
Bioequivalence based on AUCinf
Measured: Blood samples collected over 12 hour period
AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)
Bioequivalence based on AUC0-t
Measured: Blood samples collected over 12 hour period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2003Aug 2003

First posted3 Feb 2009 (estimated)
Study startJul 2003
Primary completionAug 2003
Study completionAug 2003

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HealthyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 48 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00835211
Sponsor's protocol ID: AA04887
Status last verified: Sep 2009
First submitted: 30 Jan 2009
Last updated: 11 Sep 2009
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 11 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparative, Randomized, Single-Dose, 2-way Crossover Bioavailability Study of TEVA and Aventis Pharmaceuticals (DDAVP®) 0.2 mg Desmopressin Acetate Tablets in Healthy Adult Subjects Following a 0.8 mg Dose Under Fasting Conditions
ClinicalTrials.gov ID: NCT00835211
Acronym / sponsor ID: AA04887
Conditions: Healthy
Keywords: Bioequivalence, Healthy Subjects
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 48 participants (actual)
Lead sponsor: Teva Pharmaceuticals USAIndustry (pharma, biotech, devices)
Study start: Jul 2003
Primary completion: Aug 2003 (actual)
Study completion: Aug 2003 (actual)
First posted: 3 Feb 2009 (estimated)
Results: Posted 4 Aug 2009

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

Study design

Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
1	Experimental	Drug: Desmopressin Acetate 0.2 mg Tablets
2	Active comparator	Drug: DDAVP® 0.2 mg Tablets

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (12 listed)

Healthy adult non-smoker (for at least 3 months) or light smoking (less than 10 cigarettes per day for at least 3 months) male or female subjects, 18-55 years of age;
Weighing at least 60 kg for males and 52 kg for females;
Subjects who had a body mass index (BMI) less than 30;
Medically healthy subjects with clinically normal laboratory profiles and ECGs;
Females of childbearing potential should have either been sexually inactive (abstinent) for 14 days prior to the first dose and throughout the study or have been using one of the following acceptable birth control methods:

Key exclusion criteria (15 listed)

Female subjects who were pregnant or lactating.
Subjects who had been on a special diet (for whatever reason) during the 28 days prior to the first dose and throughout the study.
Any clinically significant illness within 4 weeks prior to dosing.
Subjects with any medical condition requiring regular treatment with prescription drugs.
The use of any pharmacological agents known to significantly induce or inhibit drug-metabolizing enzymes within 30 days prior to the first dose.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Desmopressin Acetate 0.2 mg Tablets4 x 0.2 mg, single-dose fasting	Drug	1
DDAVP® 0.2 mg Tablets4 x 0.2 mg, single-dose fasting	Drug	2

Primary outcome

Cmax - Maximum Observed Concentration
Time frame: Blood samples collected over 12 hour period
Bioequivalence based on Cmax
AUCinf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)
Time frame: Blood samples collected over 12 hour period
Bioequivalence based on AUCinf
AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)
Time frame: Blood samples collected over 12 hour period
Bioequivalence based on AUC0-t

Results and safety

Results posted to the registry on 4 Aug 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Desmopressin Acetate	24	24
DDAVP®	24	23

Primary outcome: Cmax - Maximum Observed Concentration

Time frame: Blood samples collected over 12 hour period. Mean (Standard Deviation). Unit: pg/mL

Measure	Desmopressin Acetate n = 43	DDAVP® n = 43
Value	78.102 (52.5437)	82.888 (64.2238)

Desmopressin Acetate vs DDAVP®: Test/Ref Ratio of LS Means x 100: 97.5 (90% CI 87.8 to 108.3)

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

Primary outcome: AUCinf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)

Time frame: Blood samples collected over 12 hour period. Mean (Standard Deviation). Unit: pg*h/mL

Measure	Desmopressin Acetate n = 43	DDAVP® n = 42
Value	266.62 (169.435)	286.34 (199.268)

Desmopressin Acetate vs DDAVP®: Test/Ref Ratio of LS Means x 100: 95.6 (90% CI 86.9 to 105.2)

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

Primary outcome: AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)

Time frame: Blood samples collected over 12 hour period. Mean (Standard Deviation). Unit: pg*h/mL

Measure	Desmopressin Acetate n = 43	DDAVP® n = 43
Value	252.85 (162.914)	268.02 (188.907)

Desmopressin Acetate vs DDAVP®: Test/Ref Ratio of LS Means x 100: 96.5 (90% CI 87.7 to 106.1)

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

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2009.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Gaetano Morelli, M.D. principal investigator

MDS Pharma Services

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Desmopressin Acetate 0.2 mg Tablets and DDAVP® 0.2 mg Tablets in people with Healthy, run by Teva Pharmaceuticals USA at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Aug 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cmax - Maximum Observed Concentration (time frame: Blood samples collected over 12 hour period). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00835211.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2009.