Desmopressin Acetate 0.2 mg Tablets, Fasting

NCT00835211 | Completed Phase 1 Results

• 1 other identifier: AA04887
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Bioequivalence; Healthy Subjects

Outcome Measures

Primary Outcomes (3)

• Cmax - Maximum Observed Concentration

  Bioequivalence based on Cmax

  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

• 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

Study Arms (2)

1

EXPERIMENTAL

Drug: Desmopressin Acetate 0.2 mg Tablets

2

ACTIVE COMPARATOR

Drug: DDAVP® 0.2 mg Tablets

Interventions

Desmopressin Acetate 0.2 mg Tablets DRUG

4 x 0.2 mg, single-dose fasting

1

DDAVP® 0.2 mg Tablets DRUG

4 x 0.2 mg, single-dose fasting

2

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Teva Pharmaceuticals USA: lead

Study Sites (1)

MDS Pharma Sercives

Saint-Laurent, Quebec, H4R 2N6, Canada

Location

MeSH Terms

Interventions

Deamino Arginine Vasopressin

Intervention Hierarchy (Ancestors)

Arginine Vasopressin; Vasopressins; Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Results Point of Contact

• Title: Manager, Biopharmaceutics
• Organization: TEVA Pharmaceuticals USA

clinicaltrialqueries@tevausa.com

1-866-384-5525

Study Officials

• Gaetano Morelli, M.D.

  MDS Pharma Services

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 30, 2009
• First Posted: February 3, 2009
• Study Start: July 1, 2003
• Primary Completion: August 1, 2003
• Study Completion: August 1, 2003
• Last Updated: September 11, 2009
• Results First Posted: August 4, 2009

Record last verified: 2009-09

Locations

CA (1)