Status:
COMPLETED
Desmopressin Acetate 0.2 mg Tablets, Fasting
Lead Sponsor:
Teva Pharmaceuticals USA
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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 fasti...
Detailed Description
Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA bioequivalence statistical methods
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2003
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00835211
Start Date
July 1 2003
End Date
August 1 2003
Last Update
September 11 2009
Active Locations (1)
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1
MDS Pharma Sercives
Saint-Laurent, Quebec, Canada, H4R 2N6