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Sponsored by: |
PhytoHealth Corporation |
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Information provided by: | PhytoHealth Corporation |
ClinicalTrials.gov Identifier: | NCT00861549 |
The purpose of this study is to evaluate the bioavailability of two formulations (Taiwan and China mainland) of phencynonate hydrochloride tablets and to generate pharmacokinetic and safety profiles of phencynonate hydrochloride in healthy volunteers.
Condition | Intervention | Phase |
---|---|---|
Healthy |
Drug: Phencynonate hydrochloride |
Phase I |
Study Type: | Interventional |
Study Design: | Basic Science, Randomized, Open Label, Crossover Assignment |
Official Title: | Bioavailability, Pharmacokinetics and Safety Evaluation of Phencynonate Hydrochloride in Healthy Volunteers |
Estimated Enrollment: | 30 |
Study Start Date: | August 2008 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
cohort 1: Experimental
1mg / 0.5 tablet
|
Drug: Phencynonate hydrochloride
2mg/tablet
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cohort 2: Experimental
2mg / 1 tablet; crossover with Phencynonate hydrochloride (2mg/1 tablet) made in China
|
Drug: Phencynonate hydrochloride
2mg/tablet
|
cohort 3: Experimental
4mg / 2 tablets
|
Drug: Phencynonate hydrochloride
2mg/tablet
|
Ages Eligible for Study: | 18 Years to 40 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Hsiang L Ho, Master | 886-2-25453697 ext 319 | irisho@phytohealth.com.tw |
Taiwan | |
General Clinical Research Center for New Drug Trial, Tri-Service General Hospital | Recruiting |
Taipei, Taiwan, 114 | |
Contact: Hsiang L Ho, Master 886-2-25453697 ext 319 irisho@phytohealth.com.tw | |
Principal Investigator: Yaoh S Lin, M.D. |
Principal Investigator: | Yaoh S Lin, M.D. | Yaoh-Shiang Lin |
Responsible Party: | PhytoHealth Corporation ( PhytoHealth Corporation ) |
Study ID Numbers: | PH-CP005 |
Study First Received: | March 10, 2009 |
Last Updated: | March 12, 2009 |
ClinicalTrials.gov Identifier: | NCT00861549 History of Changes |
Health Authority: | Taiwan: Department of Health; Taiwan: Institutional Review Board |
Bioavailability Pharmacokinetics Safety Evaluation |
Healthy |