MED2005 (0.2% GTN) gel to be used topically in Part 1 of the study

MED2005 (0.4% GTN) gel to be used topically in Part 1 of the study

MED2005 (0.6% GTN) gel to be used topically in Part 1 of the study

3 x 0.6 mg tablets will be required to make up the 1.8 mg dose to be used orally in Part 1 of the study but to be dosed in two treatment periods

MED2005 (0.8% GTN) gel to be used topically in Part 1 of the study

GTN solution for infusion (1 mg/ml) to be used intravenously in Part 2 of the study

MED2005 (0.8% GTN) gel to be used topically in Part 2 of the study

Erectile Dysfunction

(Day -1 to Day 1): Subjects will undergo six treatment periods, each separated by at least a two day washout. Each treatment period will be approximately 1 day in duration from the afternoon of Day -1 to the afternoon of Day 1 at 6 hours (h) post-dose. In each of the treatment periods, the subject will receive one of the six administrations over 6 treatment periods (1/period) and will return approximately two days later for the next treatment period.

MED2005

Active comparator to be used for Part 1 of the study. Nitrostat will be dosed in two treatment periods and 3 x 0.6 mg tablets will be required to make up the 1.8 mg dose.

Nitrostat 0.6Mg Sublingual Tablet

to be dosed intravenously in Part 2 of the study

Nitro Pohl

Simbec Research Limited

Evaluating MED2005 & Nitrostat Bioavailability

A Single Centre, Open-label, Randomised, Single Dose, Six Period, Reference Replicate, Crossover Study to Evaluate the Bioavailability of MED2005

The primary objective of this human pharmacology study is to demonstrate similar or lower bioavailability of GTN

The percentage of drug metabolites in the bloodstream following administration of MED2005 (test formulation) with Nitrostat (reference) (part 1) will be compared and evaluated.

The incidence of treatment-emergent AEs (TEAE) will be summarised by organ system, preferred term, severity and relationship to study drug. AEs will be identified via abnormal vital signs, abnormal 12-lead ECG parameters, and/or abnormal laboratory safety data

To quantify the amount of GTN remaining on the glans penis post application of MED2005 (Part 2).

I.V. dosing to quantify a figure of 100% GTN being absorbed (Part 2).

the percentage of drug metabolites in the bloodstream following administration of MED2005 (test formulation) with Nitrostat (reference) (part 1) will be compared and evaluated.

Futura Medical Developments Ltd.

• The intervention group will be supplied with Sildenafil Citrate (Respatio® 20mg tablets manufactured by Pharma Right Group , Egypt) according to the patient's weight by the rate of (1.5 mg/kg/day) divided into three doses per day ( every 8 hours) till termination of pregnancy.

- The control group will be supplied with a placebo drug that has the same shape, size and color but without the active ingredient and it would also be taken in a similar way. The placebo tablet will be manufactured at the faculty of pharmacy, Assiut University.

Pre-Eclampsia; Mild

Sildenafil 20 MG

Placebo Oral Tablet

Assiut Univeristy Hospitals

Use of Sildenafil Citrate in Management of Mild Pre-eclampsia

Use of Sildenafil Citrate in Management of Mild Pre-eclampsia: A Randomized Controlled Trial

Gestational age at time of termination and maternal outcome in terms of whether the disease would progress to severe pre-eclampsia or not.

Neonatal outcome in terms of survival and neonatal well-being ( by obtaining the birth weight and the apgar score at 1 and 5 minutes and direct postnatal need to NICU).

Identification of possible maternal side effects from the use of sildenafil citrate i.e.; headache, flushing and dyspepsia.

Evaluation of the effect of sildenafil citrate on the feto-maternal circulation through the Doppler ultrasound.

Fady Nasef Tous Abdallah

Resident of Obstetrics and Gynecology Department - Assiut University

Assiut University

- Double blinded, randomized, placebo-controlled trial.

- It's a double blinded, randomized, placebo-controlled trial.

In three combined drugs used in nasopharyngeal carcinoma, the valproic acid and valganciclovir administration will be followed by indication to find the maximum tolerance dose of gemcitabine.

Nasopharyngeal Carcinoma

Gemcitabine will be administrated 600~1250 mg/m^2 intravenously according to the body surface area at day 1 and day 8 in a 28 day-treatment cycle. The treatment cycle of 28 days will be repeated maximum 6 times. The first dose level of gemcitabine will be started at 800 mg/m^2. If no subject suffered the dose limit toxicity, 1000 mg/m^2 and even 1250 mg/m^2 will be started by order. If subjects suffered the dose limit toxicity in 800 mg/m^2, the 600 mg/m^2 will be started.

Gemcitabine

Valproic acid will be administrated orally by the fixed dose 12.5 mg/kg/day according to instructions from day 1 to day 14 in one treatment cycle. The treatment cycle of 28 days will be repeated maximum 6 times.

Valproic acid

Valganciclovir will be administrated orally by the fixed dose 1350 mg/day (creatinine clearance rate ≥ 60 mL/min) or 900 mg/day (creatinine clearance rate ≥ 40 mL/min and < 60 mL/min) from day 9 to day 15 in one treatment cycle. The treatment cycle of 28 days will be repeated maximum 6 times.

Valganciclovir

Chang-Gung Memorial Hospital, Linkou

Study of Cytolytic Viral Activation Therapy (CVAT) for Recurrent/Metastatic Nasopharyngeal Carcinoma

Phase I Study of Cytolytic Viral Activation Therapy (CVAT) for Recurrent/Metastatic Nasopharyngeal Carcinoma

According to Worst Toxicity CTCAE v4.03 Grade and FDA indication of gemcitabine, the dose limiting toxicity (DLT) of this trial was determined in the first treatment cycle and DLTs were defined as ≥1 of the following effects attributable to the study drug and requiring discontinuation or a significant dose reduction in the study drug(s):
≥Grade 4 neutropenia >5 days;
≥Grade 4 thrombopenia lasting ≥7 days;
≥Grade 3 anemia;
≥Grade 3 neutropenic fever with a single temperature of >38.3 degree C or a sustained temperature of ≥ 38 degree C for more than one hour;
any ≥Grade 3 non-hematologic toxicity with exception of nausea and vomiting, alopecia, drug-related fever;
≥Grade 3 serum creatinine;
bone marrow and renal function didn't recover to CTCAE Grade ≤ 1 of baseline at the Day 1 of the 2nd treatment course, the treatment can be postponed less than 2 weeks. DLT was recognized when the delayed duration was more than 2 weeks.

The plasma EB virus DNA load will be check by real-time quantitative polymerase chain reaction (PCR). These data will be collected every months when subjects enter this trial and finish their final treatment cycle one weeks, 3 months, and/or 6 months later. These data will be used to supplementary data for tumor status assessment.

Chang Gung Memorial Hospital

TTY Biopharm

HCV patients treated with direct acting antivirals and ribavirin

guanosine/headache

Evaluating MED2005 & Nitrostat Bioavailability

Use of Sildenafil Citrate in Management of Mild Pre-eclampsia

Study of Cytolytic Viral Activation Therapy (CVAT) for Recurrent/Metastatic Nasopharyngeal Carcinoma

Evaluation of RIBAvirin Plasma COncentrations in Patients With Chronic Hepatitis C Infection Routinely Treated With Modern DAA Regimens

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