Desmopressin Acetate 0.2 mg Tablets, Fasting

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Desmopressin Acetate 0.2 mg Tablets; Drug: DDAVP® 0.2 mg Tablets

Detailed Description

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 1

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • St. Laurent, Quebec, Canada, H4R 2N6
      • MDS Pharma Sercives

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Drug: Desmopressin Acetate 0.2 mg Tablets; 4 x 0.2 mg, single-dose fasting
Active Comparator: 2	Drug: DDAVP® 0.2 mg Tablets; 4 x 0.2 mg, single-dose fasting

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax - Maximum Observed Concentration	Bioequivalence based on Cmax	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	Blood samples collected over 12 hour period
AUCinf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)	Bioequivalence based on AUCinf	Blood samples collected over 12 hour period

Collaborators and Investigators

• Sponsor: Teva Pharmaceuticals USA

Study record dates

Study Major Dates

• Study Start: July 1, 2003
• Primary Completion (Actual): August 1, 2003
• Study Completion (Actual): August 1, 2003

Study Registration Dates

• First Submitted: January 30, 2009
• First Submitted That Met QC Criteria: January 30, 2009
• First Posted (Estimate): February 3, 2009

Study Record Updates

• Last Update Posted (Estimate): September 11, 2009
• Last Update Submitted That Met QC Criteria: September 1, 2009
• Last Verified: September 1, 2009

More Information

Terms related to this study

• Keywords: Bioequivalence; Healthy Subjects
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Natriuretic Agents; Hemostatics; Coagulants; Antidiuretic Agents; Deamino Arginine Vasopressin
• Other Study ID Numbers: AA04887