CLINICAL TRIALS PROFILE FOR ZUPLENZ
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All Clinical Trials for ZUPLENZ
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT01217801 ↗ | Two Way Bioequivalence Study Under Fed Conditions | Completed | MonoSol Rx | Phase 1 | 2008-10-01 | The purpose of this study is to assess the single dose bioequivalence of Ondansetron ODFS 8mg with Zofran ODT® (Containing Ondansetron 8 mg) in healthy, male and female adult, human study participants under fed conditions. The purpose is to monitor clinical status, adverse events, laboratory investigations and to assess relative safety and tolerance of ondansetron formulations under fed conditions. |
| NCT01217801 ↗ | Two Way Bioequivalence Study Under Fed Conditions | Completed | Par Pharmaceutical, Inc. | Phase 1 | 2008-10-01 | The purpose of this study is to assess the single dose bioequivalence of Ondansetron ODFS 8mg with Zofran ODT® (Containing Ondansetron 8 mg) in healthy, male and female adult, human study participants under fed conditions. The purpose is to monitor clinical status, adverse events, laboratory investigations and to assess relative safety and tolerance of ondansetron formulations under fed conditions. |
| NCT01676844 ↗ | Investigating a New Way of Giving Medicine to Newborn and Preterm Babies | Unknown status | University of Strathclyde | Phase 2 | 2013-02-01 | There is a deficit in the number of 'age-appropriate' formulations available for the delivery of medicines to children. Liquid preparations are considered the 'gold standard' for delivering medicines to children however many of these are formulated using ingredients which can be toxic to children (e.g. preservatives, alcohols), particularly to neonatal babies (< 4 weeks old) who do not possess the metabolic processes and mature organ function of older children or adults. Rapidly dissolving oral thin films (OTFs) dissolve quickly in the saliva, releasing the active ingredient(s) without the need for chewing or water, making them ideally suited to patients who find it difficult to swallow other oral dosage forms such as tablets or capsules. The aim of this study is to demonstrate that OTFs can offer a safe and effective alternative for oral administration of phosphate supplements to neonatal infants for the treatment of hypophosphataemia and osteopenia of prematurity. It is hypothesised that this treatment will be equal to standard therapy using an oral solution. Babies born before 32 weeks gestational age are routinely supplemented with oral phosphate as soon as they have been established on oral feeds in order to prevent bone disorders such as osteopenia. Babies recruited to this study will be given phosphate supplementation as per NHS Greater Glasgow and Clyde guidelines. This single-centre cross-over study will take place in the intensive care and special care baby units at the Princess Royal Maternity in Glasgow. The investigators aim to recruit 20-30 babies and will use blood phosphate levels (obtained from routine sampling only) to evaluate treatment effect. Babies will be randomised to receive either OTFs or oral solution of potassium acid phosphate for 2 weeks followed by 2 weeks of the other therapy. The investigators hypothesise that OTF treatment will be equivalent to standard oral solution. |
| NCT02082678 ↗ | Ondansetron for Bipolar Disorder and Alcohol Use Disorders | Completed | Stanley Medical Research Institute | Phase 4 | 2014-02-01 | The purpose of the study is to determine if ondansetron, as an add-on therapy, is associated with reduced depressive symptoms and alcohol use in outpatients with bipolar disorder (BPD), cyclothymic disorder, schizoaffective disorder (bipolar type) and major depressive disorder (MDD) with mixed features. The investigators will also use blood samples to determine if the genotype for the serotonin transporter gene is associated with response to ondansetron. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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