Desmopressin Acetate 0.2 mg Tablets, Fasting
Condition: Healthy
Intervention: Desmopressin Acetate 0.2 mg Tablets; DDAVP® 0.2 mg Tablets
Intervention description: 4 x 0.2 mg, single-dose fasting; 4 x 0.2 mg, single-dose fasting
Intervention MeSH terms: Deamino Arginine Vasopressin
Phase: Phase 1
Study type: Interventional
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 48.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Bioequivalence; Healthy Subjects

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.
    

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.