Primary outcomeMean· Blood samples collected over 12 hour period
Cmax - Maximum Observed Concentration
| Group | Value (pg/mL) | Spread |
|---|---|---|
| Desmopressin Acetate | 78.102 | 52.5437 |
| DDAVP® | 82.888 | 64.2238 |
Trial · Interventional
CompletedPhase 1Results postedRegistry dataDesmopressin Acetate 0.2 mg Tablets, Fasting
NCTNCT00835211 (opens ClinicalTrials.gov in a new tab)Other idAA04887
Overview
- Status
- Completed
- Phase
- Phase 1
- Enrollment
- 48 participants (actual)
- Sponsor
- Teva Pharmaceuticals USA · Industry
- Design
- Randomized · Open label (no masking)
- Countries
1 country
Canada
- Start
- Jul 2003
- Primary completion
- Aug 2003
- Completion
- Aug 2003
- First posted
- 3 Feb 2009 (estimated)
- Last update posted
- 11 Sept 2009 (estimated)
- Conditions
- Healthy
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
20032004
- Ph 1
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- Desmopressin Acetate 0.2 mg TabletsDrug
- DDAVP® 0.2 mg TabletsDrug
Arms2
Experimental
1
Active comparator
2
Primary outcomes3
Outcomes the sponsor listed as primary.
Cmax - Maximum Observed Concentration
Time frame · Blood samples collected over 12 hour period
Registry description
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
Registry description
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
Registry description
Bioequivalence based on AUC0-t
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Primary outcomeMean· Blood samples collected over 12 hour period
AUCinf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)
| Group | Value (pg*h/mL) | Spread |
|---|---|---|
| Desmopressin Acetate | 266.62 | 169.435 |
| DDAVP® | 286.34 | 199.268 |
Primary outcomeMean· 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)
| Group | Value (pg*h/mL) | Spread |
|---|---|---|
| Desmopressin Acetate | 252.85 | 162.914 |
| DDAVP® | 268.02 | 188.907 |
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years up to 55 Years
- Healthy volunteers
- Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria:
* 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;
* 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.
Exclusion Criteria:
* 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.
* 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.
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