Fed Study of Nadolol/Bendroflumethiazide Tablets 80 mg/5 mg and Corzide® Tablets 80 mg/5 mg

NCT00648297 | Completed Phase 1

• 1 other identifier: NABE-0627
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study was to investigate the bioequivalence of Mylan's nadolol/bendroflumethiazide 80 mg/5 mg tablets to King's Corzide® 80 mg/5 mg tablets following a single, oral 80 mg/5 mg (1 x 80 mg/5 mg) dose administered under fed conditions.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Bioequivalence

  within 30 days

Study Arms (2)

1

EXPERIMENTAL

Nadolol/Bendroflumethiazide Tablets 80 mg/5 mg

Drug: Nadolol/Bendroflumethiazide Tablets 80 mg/5 mg

2

ACTIVE COMPARATOR

Corzide® Tablets 80 mg/5 mg

Drug: Corzide® Tablets 80 mg/5 mg

Interventions

Nadolol/Bendroflumethiazide Tablets 80 mg/5 mg DRUG

80/5mg, single dose fed

1

Corzide® Tablets 80 mg/5 mg DRUG

80/5mg, single dose fed

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18 years and older
• Sex: Male and/or non-pregnant, non-lactating female
• Women of childbearing potential must have negative serum beta human chorionic gonadotropin (β-HCG) pregnancy tests performed within 21 days prior to the start of the study and on the evening prior to each dose administration. If dosing is scheduled on weekends, serum for the HCG pregnancy test should be collected within 48 hours prior to dosing of each study period. An additional serum (β-HCG) pregnancy test will be performed upon completion of the study.
• Women of childbearing potential must practice abstinence or use an acceptable form of contraception throughout the duration of the study. Acceptable forms of contraception include the following:
• hormonal contraceptives taken throughout the study, or
• intrauterine device in place for at least 3 months prior to the start of the study and remaining in place during the study period, or
• barrier methods containing or used in conjunction with a spermicidal agent, or
• surgical sterility (tubal ligation, oophorectomy or hysterectomy) or postmenopausal accompanied with a documented postmenopausal course of at least one year.
• Hormonal replacement therapy will be allowed in this study.
• Women will not be considered of childbearing potential if one of the following is reported and documented on the medical history:
• postmenopausal with an absence of menses for at least one (1) year, or
• bilateral oophorectomy with or without a hysterectomy and an absence of bleeding for at least 6 months, or
• total hysterectomy
• During the course of the study, from study screen until study exit, all men and women of childbearing potential must use a spermicide-containing barrier method of contraception in addition to their current contraceptive device. This requirement should be documented in the informed consent form.
• Weight: At least 60 kg (132 lbs.) for men and 48 kg (106 lbs.) for women and all subjects having a Body Mass Index (BMI) greater than or equal to 19 but less than or equal to 30 (see Part II ADMINISTRATIVE ASPECTS OF BIOEQUIVALENCE PROTOCOLS).

You may not qualify if:

• Institutionalized subjects will not be used.
• Social Habits:
• Use of any tobacco products within 1 year of the start of the study.
• Ingestion of any alcoholic, caffeine- or xanthine-containing food or beverage within the 48 hours prior to the initial dose of study medication.
• Ingestion of any vitamins or herbal products within 7 days prior to the initial dose of the study medication.
• Any recent, significant change in dietary or exercise habits.
• Positive test for any drug included in the urine drug screen.
• History of drug and/or alcohol abuse.
• Medications:
• Use of any prescription or over-the-counter (OTC) medications within the 14 days prior to the initial dose of study medication (other than hormonal contraceptives and hormone replacement therapy)
• Use of any medication known to alter hepatic enzyme activity within 28 days prior to the initial dose of study medication.
• Diseases:
• History of any significant cardiovascular, hepatic, renal, pulmonary, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, or neurologic disease.
• Acute illness at the time of either the pre-study medical evaluation or dosing.
• A positive HIV, hepatitis B, or hepatitis C test result.

Sponsors & Collaborators

• Mylan Pharmaceuticals Inc: lead

Study Sites (1)

PRACS Institute, Ltd.

Fargo, North Dakota, 58104, United States

Location

Related Links

• Mylan Pharmaceuticals Inc. - Clinical Trial Results
• Daily Med - posting of most recent submitted labelling to the Food and Drug Administration (FDA) and currently in use
• Recalls, Market Withdrawals and Safety Alerts

MeSH Terms

Interventions

Nadolol; Bendroflumethiazide

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Benzothiadiazines; Sulfonamides; Sulfones; Sulfur Compounds; Thiazides; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• James D Carlson, Pharm. D.

  PRACS Institute Ltd.

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 30, 2008
• First Posted: April 1, 2008
• Study Start: August 1, 2006
• Primary Completion: August 1, 2006
• Study Completion: August 1, 2006
• Last Updated: April 23, 2024

Record last verified: 2024-04

Locations

US (1)