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| Sponsored by: |
Mylan Pharmaceuticals |
|---|---|
| Information provided by: | Mylan Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00649636 |
Purpose
The objective of this study is to investigate the bioequivalence of Mylan's fluoxetine hydrochloride 40 mg capsules to Dista's Prozac 40 mg pulvules following a single, oral 40 mg (1 x 40 mg) dose administration under fasting conditions.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: Fluoxetine Capsules 40 mg Drug: Prozac Pulvules 40 mg |
Phase I |
| Study Type: | Interventional |
| Study Design: | Randomized, Open Label, Crossover Assignment, Bio-equivalence Study |
| Official Title: | Single-Dose Fasting Bioequivalence Study of Fluoxetine Capsules (40 mg; Mylan) and Prozac Pulvules (40 mg; Dista) in Healthy Adult Volunteers |
| Enrollment: | 32 |
| Study Start Date: | February 2006 |
| Study Completion Date: | April 2006 |
| Primary Completion Date: | April 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Fluoxetine Capsules 40 mg
|
Drug: Fluoxetine Capsules 40 mg
40mg, single dose fasting
|
|
2: Active Comparator
Prozac Pulvules 40 mg
|
Drug: Prozac Pulvules 40 mg
40mg, single dose fasting
|
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. a. Women of childbearing potential must have negative serum beta human chorionic gonadotropin (b-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, the HCG pregnancy test should be given within 48 hours prior to dosing of each study period. An additional serum (b-HCG) pregnancy test will be performed upon completion of the study. b. Women of childbearing potential must practice abstinence or be using an acceptable form of contraception throughout the duration of the study. No hormonal contraceptives or hormone replacement therapy are permitted in this study.
Acceptable forms of contraception include the following: 1) 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 2) barrier methods containing or used in conjunction with a spermicidal agent, or 3) surgical sterility (tubal ligation, oophorectomy or hysterectomy) or postmenopausal accompanied with a documented postmenopausal course of at least one year. c. Women will not be considered of childbearing potential if one of the following is reported and documented on the medical history: 1) postmenopausal with an absence of menses for at least one 2) bilateral oophorectomy with or without a hysterectomy and 3) total hysterectomy d. 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.
Exclusion Criteria:
Contacts and Locations| United States, North Dakota | |
| PRACS Institute, Ltd. | |
| Fargo, North Dakota, United States, 58104 | |
| Principal Investigator: | James D Carlson, Pharm. D. | PRACS Institute Ltd. |
More Information
| Responsible Party: | Mylan Inc. ( Will Sullvan, Global Head of Product Risk and Safety Management ) |
| Study ID Numbers: | FLUO-0603 |
| Study First Received: | March 30, 2008 |
| Last Updated: | March 31, 2008 |
| ClinicalTrials.gov Identifier: | NCT00649636 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Fluoxetine Neurotransmitter Agents Psychotropic Drugs Healthy |
Antidepressive Agents, Second-Generation Serotonin Uptake Inhibitors Antidepressive Agents Serotonin |
|
Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Serotonin Uptake Inhibitors Pharmacologic Actions |
Fluoxetine Serotonin Agents Therapeutic Uses Antidepressive Agents, Second-Generation Central Nervous System Agents Antidepressive Agents |