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The objective of this study was to investigate the bioequivalence of Mylan's quinapril HCl and hydrochlorothiazide 20 mg/25 mg tablets to Parke-Davis' Accureticâ„¢ 20 mg/25 mg tablets following a single, oral 20 mg/25 mg (1 x 20 mg/25 mg) dose administered under fasting conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Quinapril HCl and Hydrochlorothiazide Tablets 20 mg/25 mg |
|
| 2 | Active Comparator | Accureticâ„¢ Tablets 20 mg/25 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quinapril HCl and Hydrochlorothiazide Tablets 20 mg/25 mg | Drug | 20/25mg, single dose fasting |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Bioequivalence | within 30 days |
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Inclusion Criteria:
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 (HCG) pregnancy tests performed within 14 days prior to the start of the study and on the evening prior to each dose administration. If dosing is scheduled on weekends, the HCG pregnancy test should be given within 48 hours prior to dosing of each study period. An additional serum (beta-HCG) pregnancy test will be performed upon completion of the study.
Women of childbearing potential must practice abstinence or be using an acceptable form of contraception throughout the duration of the study. Acceptable forms of contraception include the following:
During the course of the study, from study screen until study exit - including the washout period, women of childbearing potential must use a spermicide containing barrier method of contraception in addition to their current contraceptive device. This advice 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 within 15% of Ideal Body Weight (IBW), as referenced by the Table of ""Desirable Weights of Adults"" Metropolitan Life Insurance Company, 1999 (See Part II ADMINISTRATIVE ASPECTS OF BIOEQUIVALENCE PROTOCOLS).
All subjects should be judged normal and healthy during a pre-study medical evaluation (physical examination, laboratory evaluation, hepatitis B and hepatitis C tests, HIV test, 12-lead ECG, and urine drug screen including amphetamine, barbiturates, benzodiazepines, cannabinoid, cocaine, opiate screen, phencyclidine, and methadone) performed within 14 days of the initial dose of study medication.
Exclusion Criteria:
Institutionalized subjects will not be used.
Social Habits:
Medications:
Diseases:
Abnormal and clinically significant laboratory test results:
Donation or loss of a significant volume of blood or plasma (> 450 mL) within 28 days prior to the initial dose of study medication.
Subjects who have received an investigational drug within 30 days prior to the initial dose of study medication.
Allergy or hypersensitivity to quinapril, hydrochlorothiazide, or other related products such as other sulfonamide-derived drugs.
History of difficulties in swallowing, or any gastrointestinal disease which could affect the drug absorption.
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| Name | Affiliation | Role |
|---|---|---|
| James D Carlson, Pharm. D. | PRACS Institute Ltd. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PRACS Institute, Ltd. | Fargo | North Dakota | 58104 | United States |
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| Label | URL |
|---|---|
| Mylan Pharmaceuticals Inc. - Clinical Trial Results | View source |
| Daily Med - posting of most recent submitted labelling to the Food and Drug Administration (FDA) and currently in use | View source |
| Recalls, Market Withdrawals and Safety Alerts |
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| ID | Term |
|---|---|
| D000077583 | Quinapril |
| D006852 | Hydrochlorothiazide |
| ID | Term |
|---|---|
| D044005 | Tetrahydroisoquinolines |
| D007546 | Isoquinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Accureticâ„¢ Tablets 20 mg/25 mg |
| Drug |
20/25mg, single dose fasting |
|
| View source |
| D006571 | Heterocyclic Compounds |
| D002740 | Chlorothiazide |
| D001581 | Benzothiadiazines |
| D013449 | Sulfonamides |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D049971 | Thiazides |