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| Sponsor: | Mylan Pharmaceuticals |
|---|---|
| Information provided by: | Mylan Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00649285 |
Purpose
The objective of this study was to investigate the bioequivalence of Mylan's nitrofurantoin monohydrate/macrocrystals capsules to Procter & Gamble's Macrobid® capsules following a single, oral 100 mg (1 x 100 mg) dose under fed conditions.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: Nitrofurantoin Monohydrate/Macrocrystals Capsules 100 mg Drug: Macrobid® Capsules 100 mg |
Phase I |
| Study Type: | Interventional |
| Study Design: | Randomized, Open Label, Crossover Assignment, Bio-equivalence Study |
| Official Title: | Single-Dose Food In Vivo Bioequivalence Study of Nitrofurantoin Monohydrate/Macrocrystals Capsules (100 mg; Mylan) and Macrobid® Capsules (100 mg; Procter & Gamble) in Healthy Volunteers |
| Enrollment: | 71 |
| Study Start Date: | October 2002 |
| Study Completion Date: | November 2002 |
| Primary Completion Date: | November 2002 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Nitrofurantoin Monohydrate/Macrocrystals Capsules 100 mg
|
Drug: Nitrofurantoin Monohydrate/Macrocrystals Capsules 100 mg
100mg, single dose fed
|
|
2: Active Comparator
Macrobid® Capsules 100 mg
|
Drug: Macrobid® Capsules 100 mg
100mg, single dose fed
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Sex: Male and/or non-pregnant, non-lactating female
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:
Note: Oral contraceptive is NOT an acceptable form of contraception in this study.
Exclusion Criteria:
Social Habits:
Medications:
Diseases:
Abnormal and clinically significant laboratory test results:
Contacts and Locations| United States, West Virginia | |
| Kendle International Inc. | |
| Morgantown, West Virginia, United States, 26505 | |
| Principal Investigator: | Thomas S Clark, M.D. | Kendle International Inc. |
More Information
| Responsible Party: | Mylan Inc. ( Will Sullvan, Global Head of Product Risk and Safety Management ) |
| Study ID Numbers: | NITF-02103 |
| Study First Received: | March 30, 2008 |
| Last Updated: | March 31, 2008 |
| ClinicalTrials.gov Identifier: | NCT00649285 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Anti-Infective Agents Nitrofurantoin Therapeutic Uses |
Anti-Infective Agents, Urinary Renal Agents Pharmacologic Actions |