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Sponsored by: |
PhytoHealth Corporation |
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Information provided by: | PhytoHealth Corporation |
ClinicalTrials.gov Identifier: | NCT00766428 |
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
|
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(PCNH) |
Study First Received: | October 3, 2008 |
Last Updated: | October 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00766428 |
Health Authority: | Taiwan: Department of Health; Taiwan: Institutional Review Board |
Bioavailability Pharmacokinetics Safety Evaluation |
Healthy |