TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT00437632

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo
Description: Subjects will receive matching placebo capsules to GSK598809 orally with water.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo
Description: Subjects will receive matching placebo capsules to GSK598809 orally with water.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo
Description: Subjects will receive matching placebo capsules to GSK598809 orally with water.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Caffeine
Description: Caffeine 100 mg will be available as oral solution or tablet and subjects will receive Caffeine 100 mg orally on -1 day. On Day 35 caffeine and GSK598809 will be co-administered.
Study: NCT02954263

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: TD-1439

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Study: NCT03830827

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Vortioxetine
Description: 8-week 10-20mg/day vortioxetine; 2-hour MBRP intervention per week in 8 weeks

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Vortioxetine
Description: 8-week 10-20mg/day vortioxetine; 2-hour MBRP intervention per week in 8 weeks
Study: NCT04902092

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: High Intensity Interval Training
Description: Exercise sessions will commence with an initial 3-week accustomization period whereby training load will increase incrementally from 2 x 45min sessions with effort peaking at 60% VO2 max (week 1) increasing to 3 x 45minute with effort peaking at 80% VO2max (week 3). Participants will transition to the full HIIT protocol for the remaining weeks. The HIIT component will comprise a work-rest ratio of ≥1:1minutes, with alternating exertion epochs at \>80% VO2max and \<60% VO2max. As VO2max is likely to increase as fitness improves toward the end of the 3-month program, adjustments to HIIT will be made by the exercise physiologist based on real-time heart rate monitoring, ensuring greater accuracy in participants achieving their heart rate targets.

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Strength and Resistance Training
Description: Exercise sessions will comprise a combination of strength, coordination and mobility exercises. The strength component will consist of 2-3 sets of resistance exercises at ≤70% of a predicted 1 repetition maximum, targeting all body segments. Heart rate tracking will occur to ensure participants do not exceed 70% v02 (or exceed Lactate Threshold).
Study: NCT01287039

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Reslizumab
Description: Patients were administered intravenously over 15 to 30 minutes reslizumab at a dosage of 3.0 mg/kg at baseline and once every 4 weeks relative to baseline over 48 weeks for a total of 13 doses.
Study: NCT03049943

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: low level laser

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: low level laser
Study: NCT01311895

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: H2O
Description: 2 mg IV hydromorphone

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: 1+1
Description: 1mg I hydromorphone followed by an optional 1 mg IV hydromorphone 15 minutes later if the patient answers yes to the question, Do you want more pain medication?
Study: NCT03125018

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: LNCS ADTX Sensor
Description: Noninvasive pulse oximeter sensor.
Study: NCT01466478

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Ointment A: LEO 29102 2.5 mg/g plus calcipotriol 50 µg/g ointment
Description: once daily application, 4 weeks

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Ointment B: LEO 29102 2.5 mg/g ointment
Description: once daily application, 4 weeks

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Ointment C: Calcipotriol 50 µg/g ointment
Description: once daily application, 4 weeks

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Ointment D: LEO 29102 2.5 mg/g plus calcipotriol 50 µg/g ointment
Description: once daily application, 4 weeks

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Ointment G: LEO 29102 2.5 mg/g plus calcipotriol 50 µg/g ointment
Description: once daily application, 4 weeks

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Daivonex® ointment
Description: once daily application, 4 weeks

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Diprosone® ointment
Description: once daily application, 4 weeks
Study: NCT00633802

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Risperidone
Description: 1 mg/d risperidone for 10 weeks or placebo

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Risperidone
Description: 1 mg/d risperidone for 10 weeks or placebo
Study: NCT01287039

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Matching placebo (20 mM sodium acetate, 7% sucrose), administered intravenously (iv) once every 4 weeks over 52 weeks, for a total of 13 doses administered. Each patient received a specific volume of placebo to match the volume of reslizumab on the basis of the patient's body weight.
Study: NCT01952405

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Dialectical behavior therapy (DBT)
Description: Dialectical behavior therapy (DBT), developed by Marsha Linehan, has gained widespread popularity as a treatment for BPD, and its efficacy has been demonstrated in several trials.
Study: NCT03282474

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Sofosbuvir
Description: Sofosbuvir 400 MG Oral Tablet \[Sovaldi\]
Study: NCT01383135

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: F18-FPPRGD2
Description: Radiopharmaceutical administered for imaging, up to 14 mCi intravenous (IV).

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: F18-FPPRGD2
Description: Radiopharmaceutical administered for imaging, up to 14 mCi intravenous (IV).

Intervention type: DRUG
Group type: OTHER
Intervention: F18-FPPRGD2
Description: Radiopharmaceutical administered for imaging, up to 14 mCi intravenous (IV).
Study: NCT00972972

Intervention type: DIETARY_SUPPLEMENT
Group type: ACTIVE_COMPARATOR
Intervention: bilberry (European blueberries) and red grape juice
Description: Intervention juice: 50/50 combination of 300 ml bilberry (European blueberries) and red grape juice (Merlot grapes; Vitis Vinifera L.) per day for 9 weeks

Intervention type: DIETARY_SUPPLEMENT
Group type: PLACEBO_COMPARATOR
Intervention: placebo juice
Description: Placebo juice: 300 ml, similar to the intervention juice as to taste, energy, salt, and carbohydrates
Study: NCT01324128

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: PA21 (2.5 g tablet containing 500 mg iron)
Description: Dose range of 5.0 g/day (2 tablets/day) to 15.0 g/day (6 tablets/day).

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Sevelamer carbonate
Description: Dose range of 2.4 g/day (3 tablets/day) to 14.4 g/day (18 tablets/day)

Intervention type: DRUG
Group type: OTHER
Intervention: PA21-1 (1.25 g tablet containing 250 mg iron)
Description: Low dose comparator (1.25 g/day)
Study: NCT02370550

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cyclosporin A
Description: CsA 2-3 mg/kg/d, BID PO

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Prednisone
Description: Prednisone 0.5mg/kg/d QD PO starting at Week 0. After 2-4 weeks, the initial dose is gradually tapered by 2.5 mg each week until a maintenance dosage of 5-7.5 mg/d through week 52 (visit 6). The initial and maintenance doses are determined by the investigators of each center depending on the patients.

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Prednisone
Description: Prednisone 0.5mg/kg/d QD PO starting at Week 0. After 2-4 weeks, the initial dose is gradually tapered by 2.5 mg each week until a maintenance dosage of 5-7.5 mg/d through week 52 (visit 6). The initial and maintenance doses are determined by the investigators of each center depending on the patients.

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Placebo tablet 2-3 mg/kg/d, BID PO

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Calcium carbonate D
Description: Calcium carbonate D 600 mg, QD PO
Study: NCT01383135

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: F18-FPPRGD2
Description: Radiopharmaceutical administered for imaging, up to 14 mCi intravenous (IV).
Study: NCT02450955

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Massage
Description: A superficial massage was performed for 10 minutes in the cervical region consisting of gentle rubbing and kneading, five minutes prone and five minutes supine with a focus on cervical and suboccipital muscles in order to induce a global relaxation of the cervical and suboccipital region. Resting position. After the treatment, both groups rested for 10 minutes in a supine position with neutral ranges of neck flexion, extension, lateral flexion, and rotation.

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Occiput-Atlas-Axis Technique
Description: This technique was applied as described previously and is used with the aim of restoring joint mobility between the occiput, atlas and axis. It is a structural technique applied bilaterally, performed on a vertical axis passing through the dens process of the axis without extension or flexion and very little side-bending. After the treatment, both groups rested for 10 minutes in a supine position with neutral ranges of neck flexion, extension, lateral flexion, and rotation.
Study: NCT01952405

Intervention type: BEHAVIORAL
Group type: PLACEBO_COMPARATOR
Intervention: Dialectical behavior therapy (DBT)
Description: Dialectical behavior therapy (DBT), developed by Marsha Linehan, has gained widespread popularity as a treatment for BPD, and its efficacy has been demonstrated in several trials.
Study: NCT00745823

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Comparator: Raltegravir 400 mg b.i.d.
Description: Raltegravir 400 mg tablet by mouth (PO) twice daily (b.i.d.) + two raltegravir placebo tablets + one tablet of TRUVADA™ once daily (q.d.)

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Experimental: Raltegravir 800 mg q.d.
Description: Raltegravir 800 mg tablet PO q.d. + two raltegravir placebo tablets + one tablet TRUVADA™ q.d.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: TRUVADA™
Description: One tablet TRUVADA™ q.d. (fixed combination 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate)

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: TRUVADA™
Description: One tablet TRUVADA™ q.d. (fixed combination 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate)
Study: NCT03613545

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: fecal microbiota transplantation
Description: 200 mL of prepared fecal microbiota suspension from heathy donors' fresh feces was injected into the colon

Intervention type: PROCEDURE
Group type: SHAM_COMPARATOR
Intervention: Infusion of sham
Description: Infusion of sham

Intervention type: DRUG
Group type: SHAM_COMPARATOR
Intervention: probiotics, antibiotics or antidepressants
Description: Drugs such as probiotics, antibiotics, antidepressants
Study: NCT03200405

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: DynaMeshVisible
Description: The umbilical hernias will be fixed with a mesh. In this group a MRI-visible mesh will be used.

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: DynaMeshCICAT
Description: The umbilical hernias will be fixed with a mesh. In this group a non-visible mesh will be used.
Study: NCT02968901

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: macitentan
Description: used in open label
Study: NCT02370550

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Calcium carbonate D
Description: Calcium carbonate D 600 mg, QD PO
Study: NCT02968901

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: tadalafil
Description: used in open label
Study: NCT02519036

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: ISIS 443139 10 mg
Description: ISIS 443139, 10 mg, was administered by intrathecal injection, on Study Days 1, 29, 57, and 85.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: ISIS 443139 30 mg
Description: ISIS 443139, 30 mg, was administered by intrathecal injection, on Study Days 1, 29, 57, and 85.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: ISIS 443139 60 mg
Description: ISIS 443139, 60 mg, was administered by intrathecal injection, on Study Days 1, 29, 57, and 85.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: ISIS 443139 90 mg
Description: ISIS 443139, 90 mg, was administered by intrathecal injection, on Study Days 1, 29, 57, and 85.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: ISIS 443139 120 mg
Description: ISIS 443139, 120 mg, was administered by intrathecal injection, on Study Days 1, 29, 57, and 85.

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Placebo was administered by intrathecal injection, on Study Days 1, 29, 57, and 85.
Study: NCT03159767

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: ViMove Spinal Sensor
Description: Sensors will be used to measure spinal movement

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: ViMove Spinal Sensor
Description: Sensors will be used to measure spinal movement
Study: NCT04803370

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Convalescent Plasma with antibody against SARS-CoV-2.
Description: Convalescent plasma plus standard treatment for COVID-19. The convalescent plasma is from patients recovered from COVID-19 and negative viremia in the test detection COVID-19.~The infusions will be given on days 1 and 2, of the study, after the positive result for COVID-19 of the recipient patient.

Intervention type: OTHER
Group type: OTHER
Intervention: Standard treatment for COVID-19
Description: The patients will receive the standard treatment for COVID-19, according to guidelines for COVID-19 (retrovirals drugs, interferon-α / β, anti-Interleukin-6 monoclonal antibody, oxygen therapy, etc..)
Study: NCT02418702

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: 0.2 mg/kg ketamine
Description: 20 patients will randomly be assigned 0.2 mg/kg of Ketamine

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: placebo
Description: 20 patients will randomly be assigned a placebo
Study: NCT02073760

Intervention type: OTHER
Intervention: There is no intervention. The investigators are interviewing cardiac surgery staff with knowledge of infection prevention.
Description: The investigators will conduct tape recorded interviews with hospital staff about infection prevention.
Study: NCT01671891

Intervention type: RADIATION
Intervention: radiation therapy
Description: 45-55Gy
Study: NCT01955096

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: fast-track surgery
Description: The included patients will be randomly divided to two groups :30 that will undergo LAG with FTS rehabilitation programme and 31 that also will undergo LAG but receive conventional postoperative care.Laparoscopy-assisted gastrectomy will be carried out in this approach.There will be no difference in the surgical procedures of both groups.The criteria for discharge are: tolerance of solid diet, return of bowel habits and ability to walk on their own.

Intervention type: PROCEDURE
Group type: OTHER
Intervention: conventional postoperative care
Description: The included patients will be randomly divided to two groups :30 that will undergo LAG with FTS rehabilitation programme and 31 that also will undergo LAG but receive conventional postoperative care.Laparoscopy-assisted gastrectomy will be carried out in this approach.There will be no difference in the surgical procedures of both groups.The criteria for discharge are: tolerance of solid diet, return of bowel habits and ability to walk on their own.
Study: NCT01419678

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: collection of blood samples for PK testing
Description: PK samples collected around dosing of posaconazole
Study: NCT00769470

Intervention type: BIOLOGICAL
Group type: ACTIVE_COMPARATOR
Intervention: trastuzumab
Description: Given IV

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: trastuzumab
Description: Given IV

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: carboplatin
Description: Given IV

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: carboplatin
Description: Given IV

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: carboplatin
Description: Given IV

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: docetaxel
Description: Given IV

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: docetaxel
Description: Given IV

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: docetaxel
Description: Given IV

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: lapatinib ditosylate
Description: Given orally

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: lapatinib ditosylate
Description: Given orally
Study: NCT01671891

Intervention type: DRUG
Intervention: capecitabine (625mg/m2,bid,d1-5 qw)and oxaliplatin (85mg/m2 d1 qw)
Description: radiotherapy concurrent chemotherapy(capecitabine+oxaliplatin)
Study: NCT01668134

Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: Stereotactic radiation
Study: NCT04203017

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: allogeneic fecal microbiota
Description: All patients receive autoHSCT with RIC (Cyclophosphamide, Antithymocyte globulin, Rituximab). After immune system reconstitution (approximately starting D+60 up to D+120), patients will receive FMT from healthy donor via po capsules.
Study: NCT04337723

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: ABI/WIFI scoring
Description: The initial ABI training workshop will be coordinated by the non-physician clinic staff champion, and all non-provider clinic staff will be asked to participate. The PI and a research assistant will conduct a 1.5-hour telemedicine training session instructing clinical staff in ABI measurement and WIfI and scoring, using the clinical scoring sheet. Following didactic teaching, participants will perform ABI tests under the guidance of the PI/research assistant and with the support of other participants. During each part of the workshop, specific attention will be directed to pitfalls and technical errors of the test. A pre-post assessment will be used to ensure comprehension of key concepts and performance of the ABI and WIfI tools.
Study: NCT03930303

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Multimedia- based patient education
Description: Patients will receive a 5 minutes video education before D\&C
Study: NCT02998255

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Single dose of 2L PEG
Description: Patients at average risk for inadequate BP were given instructions for bowel preparation through phone call a day before scheduled colonoscopy. Patients began to drink 2 L of PEG 4-6 hours before colonoscopy at a rate of 250 mL every 15 minutes.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Split dose of 4L PEG
Description: All patients at average risk for inadequate BP were given instructions for bowel preparation through phone call a day before scheduled colonoscopy. the participants began to drink the first 2 L of PEG at 7:00-9:00 PM on the day before colonoscopy at a rate of 250 mL every 15 minutes. On the day of the procedure, patients took the remaining 2 L 4-6 hours before colonoscopy.
Study: NCT03275012

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Gabapentin + Morphine
Description: Gabapentin: liquid oral formulation (syrup) - 75 mg/ml-three times daily. The starting dose during the optimization period will be defined according to 2 weight groups (5-15kg and \>15kg). Dose will be scaled at Day 1,3,5,14,and 21 according to a specific schedule. Maintenance dosing will be scheduled in accordance to the body weight.~Morphine: background therapy as oral, liquid and solid formulations. Patients with BW≤30kg :liquid oral formulation four times daily throughout the whole treatment period. Patients with BM\>30kg : immediate release solid and/or liquid oral formulation four times daily during titration phase and an extended release solid oral formulation twice daily during the maintenance period.

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo + Morphine
Description: Placebo liquid oral formulation. Morphine: background therapy as oral, liquid and solid formulations. Patients with BW≤30kg :liquid oral formulation four times daily throughout the whole treatment period. Patients with BM\>30kg : immediate release solid and/or liquid oral formulation four times daily during titration phase and an extended release solid oral formulation twice daily during the maintenance period.
Study: NCT02637284

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Bepecin
Description: Phase 1a: Healthy volunteers will take a single dose of 1, 3 or 6 tablets by mouth of PCO-02 containing 1 mg of Bepecin to study safety and pharmacokinetics.~Phase 1b: All subjects will take 3 tablets of PCO-02 containing 1 mg of Bepecin every 8 hours during two weeks, to study safety and pharmacokinetics.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Bepecin
Description: Phase 1a: Healthy volunteers will take a single dose of 1, 3 or 6 tablets by mouth of PCO-02 containing 1 mg of Bepecin to study safety and pharmacokinetics.~Phase 1b: All subjects will take 3 tablets of PCO-02 containing 1 mg of Bepecin every 8 hours during two weeks, to study safety and pharmacokinetics.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Bepecin
Description: Phase 1a: Healthy volunteers will take a single dose of 1, 3 or 6 tablets by mouth of PCO-02 containing 1 mg of Bepecin to study safety and pharmacokinetics.~Phase 1b: All subjects will take 3 tablets of PCO-02 containing 1 mg of Bepecin every 8 hours during two weeks, to study safety and pharmacokinetics.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Bepecin
Description: Phase 1a: Healthy volunteers will take a single dose of 1, 3 or 6 tablets by mouth of PCO-02 containing 1 mg of Bepecin to study safety and pharmacokinetics.~Phase 1b: All subjects will take 3 tablets of PCO-02 containing 1 mg of Bepecin every 8 hours during two weeks, to study safety and pharmacokinetics.

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Phase 1 a: Healthy volunteers will take a single dose of 1, 3 or 6 tablets by mouth of PCO-03 (placebo) as a control group.~Phase 1b: All subjects will take 3 tablets of PCO-03 (placebo) every 8 hours during two weeks, as a control group.

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Phase 1 a: Healthy volunteers will take a single dose of 1, 3 or 6 tablets by mouth of PCO-03 (placebo) as a control group.~Phase 1b: All subjects will take 3 tablets of PCO-03 (placebo) every 8 hours during two weeks, as a control group.

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Phase 1 a: Healthy volunteers will take a single dose of 1, 3 or 6 tablets by mouth of PCO-03 (placebo) as a control group.~Phase 1b: All subjects will take 3 tablets of PCO-03 (placebo) every 8 hours during two weeks, as a control group.