AIM-Harvard/TrialPanorama-filtered huggingface dataset:
Study NCT01628081 — intervention group
Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: Dunaliella Bardawil
Description: Dosage Regimen and Treatment Groups~* Daily oral administration of:~* Dunaliella, 6 capsules/day (3 capsules in the morning, 3 in the evening).~* Placebo, 6 capsules/day (3 capsules in the morning, 3 in the evening).
Study NCT01531673 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Ivacaftor
Study NCT01531673 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Ivacaftor
Study NCT01531673 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo matched to VX-661
Study NCT02862080 — intervention group
Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: anode tsDCS
Description: Non-invasive electrical stimulation, transcutaneous spinal direct current stimulation (tsDCS) is the application of electrical current to the spinal cord via surface electrodes placed on the skin.
Study NCT01839747 — intervention group
Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: PET-MRI
Description: Imaging
Study NCT01839747 — intervention group
Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: PET-CT
Description: Imaging
Study NCT01803659 — intervention group
Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: b-carotene
Study NCT01803659 — intervention group
Intervention type: DIETARY_SUPPLEMENT
Group type: ACTIVE_COMPARATOR
Intervention: retinyl palmitate
Study NCT01803659 — intervention group
Intervention type: DIETARY_SUPPLEMENT
Group type: PLACEBO_COMPARATOR
Intervention: placebo
Study NCT01462630 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: pazopanib hydrochloride
Description: Given PO
Study NCT01462630 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: laboratory biomarker analysis
Description: Correlative studies
Study NCT01462630 — intervention group
Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: positron emission tomography
Description: Correlative studies
Study NCT01462630 — intervention group
Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: computed tomography
Description: Correlative studies
Study NCT01462630 — intervention group
Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: fludeoxyglucose F 18
Description: Correlative studies
Study NCT03943628 — intervention group
Intervention type: BEHAVIORAL
Group type: OTHER
Intervention: Familias Unidas
Study NCT03943628 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Familias Unidas
Study NCT00164138 — intervention group
Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Pelvic floor training group
Description: pelvic floor training, electrotherapy, bladder retraining.
Study NCT03744897 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Hypnotic analgesia
Description: Subjects will receive hypnotic analgesia during 20 minutes
Study NCT03744897 — intervention group
Intervention type: DEVICE
Group type: SHAM_COMPARATOR
Intervention: a-tDCS
Description: Subjects will receive transcranial direct stimulation over bilateral DLPFC left/anode right/cathodal, 2mA, 20 minutes
Study NCT03744897 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Hypnotic analgesia + a-tDCS
Description: Subjects will receive hypnotic analgesia associated to transcranial direct stimulation over bilateral DLPFC left/anode right/cathodal, 2mA, 20 minutes
Study NCT03744897 — intervention group
Intervention type: OTHER
Group type: SHAM_COMPARATOR
Intervention: Hypnotic analgesia + a-tDCS
Description: Subjects will receive hypnotic analgesia associated to transcranial direct stimulation over bilateral DLPFC left/anode right/cathodal, 2mA, 20 minutes
Study NCT03744897 — intervention group
Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: s-tDCS
Description: Subjects will receive sham transcranial direct stimulation over bilateral DLPFC left/anode right/cathodal, 0mA, 20 minutes
Study NCT02227277 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Peg-IFN-α2b
Description: Arm 1: At week 4 of the treatment, ART will be interrupted. Viral load will be monitored every 2 weeks. ART will be resumed at the earlier of a) a single measurement of VL > 50 c/ml or b) 16 weeks of treatment, and subjects will be observed for the remaining 4 weeks (total of 20 weeks on treatment).~Arm 2: In week 4, participants in arm 2 will add peg-IFN-α-2b to their ART regimen for a period of 20 weeks.
Study NCT03943498 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Fingolimod
Description: Given PO daily for 4 weeks
Study NCT03943498 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Fingolimod Hydrochloride
Description: Given PO
Study NCT03943498 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Questionnaire Administration
Description: Ancillary studies
Study NCT02925858 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Normal Saline Flush, 0.9% Injectable Solution_#1
Description: Normal saline infusion mimicking infusion rate of ketamine for a given weight
Study NCT02925858 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Ketamine Hydrochloride
Description: Ketamine IV infusion (0.5mg/kg bolus prior to incision, 0.5mg/kg/hr until the end of surgery)
Study NCT00413543 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: early pulmonary lung rehabilitation
Description: early pulmonary rehabilitation, 10 days after discharge
Study NCT02849743 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Syntocinon
Description: The active substance of Syntocinon is a synthetic nonapeptide identical to the posterior pituitary hormone oxytocin.
Study NCT02849743 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo (for Syntocinon)
Description: The placebo is identical to the Syntocinon formulation with the exception of the active compound, i.e., without oxytocin.
Study NCT03323112 — intervention group
Intervention type: BIOLOGICAL
Intervention: influenza vaccine
Description: Vaccine for prevention of influenza. Vaccines change by influenza season.
Study NCT02635308 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Unilaterally Biased Resistance Training / MOVE
Description: High-intensity resistance training including: whole body movement patterns, unilaterally biased lower extremity strength training, task-oriented balance tasks
Study NCT01759706 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Enhanced recovery after surgery protocol
Description: ERAS items implemented were: preadmission counselling, preoperative immunonutrition, no preoperative bowel preparation, epidural analgesia, no pre-anesthetic medication, intraoperative iv fluid restriction, PONV and hypothermia prophylaxis, removal of nasogastric tube (NGT) at the end of surgery, mobilization protocol, solid food diet from POD 2, early stop of iv infusions and removal of urinary catheter.
Study NCT01759706 — intervention group
Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Standard perioperative care
Description: Epidural analgesia, pre-anesthetic medication with diazepam, bowel preparation with oral assumption of sodium phosphate, removal of nasogastric tube on POD 1, solid food diet from POD 4
Study NCT01759706 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: PONV prophylaxis with Ondansetron + Dexamethasone
Description: Postoperative nausea and vomiting prophylaxis with Ondansetron + Dexamethasone.
Study NCT01759706 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Postoperative mobilization program
Description: Patient mobilization for 2 hours on first postoperative day Patient mobilization for 4 hours on first postoperative day + assisted deambulation in the room Patient mobilization for 6 hours on first postoperative day + assisted deambulation in the ward
Study NCT01759706 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Epidural analgesia with naropin + sufentanil
Description: Midthoracic epidural analgesia with naropin 0.2 % plus sufentanil 0,5 mcg/mL
Study NCT01759706 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Epidural analgesia with naropin + sufentanil
Description: Midthoracic epidural analgesia with naropin 0.2 % plus sufentanil 0,5 mcg/mL
Study NCT01759706 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Pre-anesthetic medication with diazepam
Description: Premedication before general anesthesia
Study NCT01759706 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Preadmission counselling
Description: Patient multidisciplinary preoperative counselling, including anesthesiologist, surgeon and nurse.
Study NCT01759706 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Preoperative bowel preparation with sodium phosphate
Description: Preoperative bowel preparation with oral assumption of sodium phosphate
Study NCT03250689 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Danirixin
Description: Danirixin will be available as 35 mg oval shaped, white film coated HBr embossed tablets.
Study NCT03250689 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo
Description: Placebo will be available as oval shaped, white film coated tablets.
Study NCT03250689 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Rescue medication
Description: Subjects may continue to use rescue medication(s) anytime during the study. The following rescue medications may be used: short acting beta agonists, short acting muscarinic antagonists, or short acting combination bronchodilators.
Study NCT01531673 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo matched to ivacaftor
Study NCT01531673 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo matched to ivacaftor
Study NCT01508624 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Interaction
Description: Participants in this condition will interact with nurses during their surgery. The nurses will not touch the patient's hand during treatment as this intervention looks at interaction with another person, in the absence of tactile stimuli.
Study NCT01508624 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Music
Description: Participants will be offered a choice of music to listen to from a selection at the clinic, they will also have the opportunity of bringing or selecting their own music which can be streamed from the internet. They will listen to the music through headphones
Study NCT01508624 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Touch - stress balls
Description: Participants will be provided with two stress balls which they will be encouraged to squeeze during their surgery and administration of the local anaesthetic
Study NCT01508624 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: DVD
Description: participants will be given a choice of DVDs to watch during their procedure. A wall mounted screen will be positioned so that participants can comfortably view the screen during their procedure. they will listen to the accompanying audio through wireless headphones.
Study NCT02490033 — intervention group
Intervention type: DEVICE
Group type: OTHER
Intervention: Ablation Catheter
Study NCT02311673 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Setmelanotide
Description: subcutaneous injection
Study NCT02311673 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Subcutaneous injection
Study NCT02385240 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Brimonidine Topical Gel, 0.33 percent (Perrigo)
Study NCT02385240 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Brimonidine Topical Gel, 0.33 percent (Reference)
Study NCT02385240 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo gel
Study NCT01006252 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Tasisulam-sodium
Description: Administered intravenously on Day 1 of a 28-day cycle, until disease progression.
Study NCT01006252 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Paclitaxel
Description: 80 mg/m\^2 administered intravenously on Days 1, 8, and 15 of a 28-day cycle, until disease progression
Study NCT04263272 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Upper Body Circuit Training Program
Description: 16 week seated upper body exercise for persons with Spinal Cord Injuries. Participants will attend 2-3 exercise sessions a week, sessions have a mix of SCI community members and inpatients.
Study NCT01355861 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Negative work exercise
Description: Submaximal negative work exercise using an isokinetic dynamometer will be performed twice per week for 12 weeks. Exercise volume will be 3 sets of 10 repetitions for the knee and shoulder extensors.
Study NCT01355861 — intervention group
Intervention type: BEHAVIORAL
Group type: OTHER
Intervention: Negative work exercise
Description: Submaximal negative work exercise using an isokinetic dynamometer will be performed twice per week for 12 weeks. Exercise volume will be 3 sets of 10 repetitions for the knee and shoulder extensors.
Study NCT01325753 — intervention group
Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: cryotherapy
Description: Undergo CT-guided CA
Study NCT01325753 — intervention group
Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: quality-of-life assessment
Description: Ancillary studies
Study NCT04633525 — intervention group
Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Optimum Cup Orientation
Description: Participants will have X-rays taken before surgery to determine the target optimal zone for orientation of the cup implant, using EBRA software. The surgeon may or may not implant in this target zone, depending on what they believe is in the patient's best interest. X-rays will be taken at 12 months after surgery to determine if they target cup orientation was achieved.
Study NCT04307940 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Naproxen Sodium (Aleve, BAY117031)
Description: 220 mg per tablet, two tablets (440 mg), intake a single dose orally.
Study NCT04307940 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Hydrocodone/Acetaminophen
Description: 5/325 mg per tablet, two tablets (10/650 mg), intake a single dose orally.
Study NCT04307940 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: two tablets, intake a single dose orally.
Study NCT04078295 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: E7389-LF
Description: E7389-LF Intravenous infusion.
Study NCT03250689 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Inhaled COPD maintenance medication
Description: Subjects may continue to use inhaled COPD maintenance medication(s) during the study, at the discretion of the GSK Medical Monitor and/or Investigator. The following maintenance medications may be used: long acting bronchodilator medications (e.g. long-acting muscarinic antagonist \[LAMA\], long-acting beta-agonist \[LABA\]) and long-acting bronchodilator combination therapies (e.g. LAMA/LABA) and long-acting bronchodilator/inhaled corticosteroid steroid combination (ICS) therapies (e.g. LABA/ICS, LAMA/LABA/ICS)
Study NCT04078295 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Nivolumab
Description: Nivolumab Intravenous infusion.
Study NCT01977677 — intervention group
Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: radiation therapy
Description: Undergo radiation therapy
Study NCT01977677 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: temozolomide
Description: Given PO
Study NCT01977677 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: plerixafor
Description: Given IV
Study NCT01977677 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: laboratory biomarker analysis
Description: Correlative studies
Study NCT01977677 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: pharmacological study
Description: Correlative studies
Study NCT03729401 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Active Comparator: Dual Antiplatelet Therapy (DAPT) - Aspirin 81 mg + Ticagrelor 60mg twice daily
Description: DAPT with aspirin and ticagrelor
Study NCT02318849 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Web intervention
Description: interactive website using social media and gamification
Study NCT03184311 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: High-intensity interval training (HIT)
Description: Supervised 12-week HIT 3 times per week on a bicycle ergometer.
Study NCT03184311 — intervention group
Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Moderate-intensity contiuous training (MCT)
Description: Supervised 12-week MCT 3 times per week on a bicycle ergometer.
Study NCT03492229 — intervention group
Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: tDCS
Description: 1 mA of tDCS
Study NCT03492229 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: tDCS
Description: 1 mA of tDCS
Study NCT03492229 — intervention group
Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: AMT
Description: Ankle motor training
Study NCT03492229 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: AMT
Description: Ankle motor training
Study NCT03492229 — intervention group
Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Treadmill training
Description: High intensity treadmill training
Study NCT03492229 — intervention group
Intervention type: BEHAVIORAL
Group type: SHAM_COMPARATOR
Intervention: Treadmill training
Description: High intensity treadmill training
Study NCT03492229 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Treadmill training
Description: High intensity treadmill training
Study NCT01136018 — intervention group
Intervention type: PROCEDURE
Intervention: insertion needle via intentionally lateral direction.
Description: evaluation of iodinated contrast flow patterns in caudal epidurography with intentional lateral caudal approach
Study NCT03335800 — intervention group
Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Apple Heart Study App
Description: The Apple Heart Study app is a mobile medical app that analyzes pulse rate data. The app identifies episodes of irregular heart rhythms consistent with atrial fibrillation and other arrhythmias.
Study NCT05549583 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Sitagliptin/metformin hydrochloride (HCl) 50/1000 mg film-coated tablet
Description: The subjects randomly received single oral dose of Sitagliptin/metformin hydrochloride (HCl) 50/1000 mg film-coated tablet
Study NCT02193750 — intervention group
Intervention type: DIETARY_SUPPLEMENT
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: 1 placebo muesli bar and 1 serving placebo muesli per day (0.55 g total fructans/GOS)
Study NCT02193750 — intervention group
Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: Moderate Oligosaccharide Group
Description: 1 placebo muesli bar and 1 serving intervention muesli per day (3.25 g total fructans/GOS)
Study NCT02193750 — intervention group
Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: High Oligosaccharide Group
Description: 1 placebo muesli bar and 1 serving placebo muesli per day (5.43 g total fructans/GOS)
Study NCT01566604 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: NVA237
Description: Delivered via a single dose dry powder inhaler
Study NCT01566604 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Delivered via a single dose dry powder inhaler
Study NCT03049878 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Paracetamol Codeine
Description: preoperative administration
Study NCT03049878 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo Oral Tablet
Description: preoperative administration
Study NCT02903342 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Leaflet
Description: A leaflet designed from data obtained from previous qualitative and quantitative studies.
Study NCT01204203 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Zometa
Description: Zoledronic acid will be administered IV on the first day of a 21 day cycle at a concentration of 4 mg. The treatment will take about 30-60 minutes with the infusion lasting about 15 minutes.
Study NCT01122069 — intervention group
Intervention type: OTHER
Intervention: Perflutren Lipid Microsphere ultrasound contrast
Description: Perflutren Lipid Microsphere ultrasound contrast 0.01 ml/kg administered as intravenous bolus
Study NCT01973218 — intervention group
Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Meningococcal B Recombinant vaccine rMenB+OMV NZ
Description: Subjects were randomized to one of two treatment groups to receive intramuscular (IM) vaccination with two doses of rMenV+OMV NZ vaccine (0.5 mL) in the non-dominant arm, one month apart. Subjects were followed for two months.
Study NCT01973218 — intervention group
Intervention type: BIOLOGICAL
Group type: ACTIVE_COMPARATOR
Intervention: Placebo
Description: Subjects were randomized to one of two treatment groups to receive intramuscular (IM) injection of saline solution followed by one dose of MenACWY-CRM vaccine (0.5 mL), one month apart. Subjects were followed for two months.
Study NCT01973218 — intervention group
Intervention type: BIOLOGICAL
Group type: ACTIVE_COMPARATOR
Intervention: Meningococcal ACWY-CRM conjugate vaccine
Description: Subjects were randomized to one of two treatment groups to receive intramuscular (IM) injection of saline solution followed by one dose of MenACWY-CRM vaccine (0.5 mL), one month apart. Subjects were followed for two months.
Study NCT04322032 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Reference drug
Description: D759 Tab. 1 Tab. and D308 Tab. 1 Tab.(Total 2 Tab.), Single oral administration under fasting condition.
Study NCT04322032 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Test drug
Description: CKD-389 Tab. 1 Tab.(Total 1 Tab.), Single oral administration under fasting condition.