Pharmacokinetics of Asacol 2.4 g/Day and Lialda 2.4 g/Day in Healthy Volunteers
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| ClinicalTrials.gov Identifier: NCT00751699 |
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Recruitment Status :
Completed
First Posted : September 12, 2008
Last Update Posted : April 17, 2013
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Sponsor:
Warner Chilcott
Information provided by (Responsible Party):
Warner Chilcott
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Brief Summary:
This study evaluated pharmacokinetics of 5-ASA and N-Ac-5-ASA associated with each of 3 regimens of oral mesalamine 2.4 g/day (Lialda 2.4 g/day 2 x 1.2 g every 24 hours, Asacol® 6 x 400 mg every 24 hours, or Asacol 2 x 400 mg every 8 hours). Primary endpoints were 5-ASA area under the plasma concentration versus time curve from zero to 24 hours (AUC24) and total 5-ASA percent of dose excreted (A'e [%]) over the 24-hour period on Day 7.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Healthy | Drug: Asacol Drug: Lialda | Phase 1 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 37 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Official Title: | A Randomized, Open-label, Multiple Dose, Parallel Group Study to Evaluate 5 ASA and N Ac 5 ASA Pharmacokinetics Following Administration of Oral Doses of Asacol 2.4 g/Day and Lialda 2.4 g/Day for 7 Days in Healthy Volunteers |
| Study Start Date : | March 2007 |
| Actual Primary Completion Date : | April 2007 |
| Actual Study Completion Date : | April 2007 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Experimental: 1
Asacol 6x400 mg Q24h at 7 am for 7 days
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Drug: Asacol
Asacol tablets, 6 tablets per day at 7 am for 7 days |
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Experimental: 2
Asacol 2x400 mg Q8h at 7 am, 3 pm, and 11 pm for 7 days
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Drug: Asacol
Asacol tablets, 400 mg, 2 tablets at 7 am, 3 pm, and 11 pm for 7 days |
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Experimental: 3
Lialda 2x1.2g Q24h at 7 am for 7 days
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Drug: Lialda
Lialda tablets 1.2 g, 2 tablets once a day at 7 am for 7 days |
Primary Outcome Measures :
- Pharmacokinetic endpoints of primary interest include AUC24 and the amount of 5-ASA excreted in the urine by subjects dosed with Asacol and Lialda. [ Time Frame: Day 7 ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Males or females between 18 and 45 years of age, inclusive, at screening and in good general health based on medical history, physical examination, and laboratory evaluation;
- If female, must be (as documented by patient reported medical history):
- postmenopausal (at least 1 year without spontaneous menses), or
- surgically sterile (tubal ligation or hysterectomy), or
- using acceptable contraception [e.g., sexual partner with non-reversed vasectomy (with azoospermia in 2 tests), 2 barrier methods (e.g., condom, diaphragm, or spermicide), or intra-uterine device];
- Body mass index (BMI) between 18 and 32 kg/m2, inclusive;
- Able to swallow the assigned study medication tablet whole; and,
- Able to fulfill the requirements of the protocol and provide written informed consent.
Exclusion Criteria:
- History or presence of any condition or gastrointestinal (GI) surgery causing malabsorption or an effect on GI motility;
- Any uncontrolled acute disease or major surgical operation requiring hospitalization within 1 month of screening;
- History of diabetes, syncope, cardiovascular, hepatic, or renal disease;
- Uncontrolled chronic diseases such as hypertension, systemic lupus erythematosus, or rheumatoid arthritis;
- History of cancer within the last 5 years (except for basal cell carcinoma with a documented 6-month remission);
- Any known enzyme-inducer, enzyme-inhibitor, or reported chronic exposure to enzyme-inducers such as paint solvents or pesticides within 30 days of treatment;
- Any prescription drug or herbal remedy within 14 days prior to scheduled dosing
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00751699
Locations
| United States, Florida | |
| Research Site | |
| Miami, Florida, United States | |
Sponsors and Collaborators
Warner Chilcott
Investigators
| Study Director: | William S Aronstein, MD, PhD | Procter and Gamble |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Warner Chilcott |
| ClinicalTrials.gov Identifier: | NCT00751699 |
| Other Study ID Numbers: |
2007011 |
| First Posted: | September 12, 2008 Key Record Dates |
| Last Update Posted: | April 17, 2013 |
| Last Verified: | April 2013 |
Keywords provided by Warner Chilcott:
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Pharmacokinetics |
Additional relevant MeSH terms:
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Mesalamine Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents |