Clinical trial NCT00835211: Desmopressin Acetate 0.2 mg Tablets, Fasting
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Bioequivalence
Healthy Subjects
Lead sponsor: Teva Pharmaceuticals USA
Sponsor class: INDUSTRY
First posted: 2009-02-03
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief 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.

Detailed description: Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

Eligibility criteria: 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.

Primary outcomes:
measure: Cmax - Maximum Observed Concentration
timeFrame: Blood samples collected over 12 hour period
measure: AUCinf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)
timeFrame: Blood samples collected over 12 hour period
measure: AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)
timeFrame: Blood samples collected over 12 hour period
Secondary outcomes:
Other outcomes:
Locations:
city: St. Laurent
country: Canada
facility: MDS Pharma Sercives
state: Quebec
Study officials:
affiliation: MDS Pharma Services
name: Gaetano Morelli, M.D.
role: PRINCIPAL_INVESTIGATOR
References: